Safety and Efficacy of Combining Intranasal Insulin & Acute Exercise
Sponsor
Michigan State University (Other)
Overall Status
Completed
CT.gov ID
NCT04292535
Collaborator
(none)
116
1
2
20.2
5.7
Study Details
Study Description
Brief Summary
To determine if physical activity engagement alters the dose-response profile and safety of administration of insulin into the intranasal mucosa.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Using a randomized placebo controlled double-blind pre-posttest design, participants will be randomly assigned to receive a dose of either 0, 20, 40, 60, 80, 100, or 120 IU of NovoLog insulin aspart prior to being randomized into participating in a 20 minute session of either moderate-intensity aerobic exercise or a passive control condition. The efficacy of the intranasal insulin for inducing alterations in cognition will be assessed using both behavioral and neuroelectric measures. The safety of the protocol will be assessed using a symptom questionnaire assessing common symptoms of altered blood glucose and common side effects of intranasal insulin.
Study Design
Study Type:
Interventional
Actual Enrollment
:
116 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Random allocation to a dose of intranasal insulin (0, 20, 40, 60, 80, 100, 120) Within each dose, random allocation to exercise or control activity.Random allocation to a dose of intranasal insulin (0, 20, 40, 60, 80, 100, 120) Within each dose, random allocation to exercise or control activity.
Masking:
Double (Participant, Investigator)
Masking Description:
Double blind, placebo controlled trial
Primary Purpose:
Treatment
Official Title:
Placebo Controlled Phase II Clinical Trial: Safety and Efficacy of Combining Intranasal Insulin & Acute Exercise
Actual Study Start Date
:
Jun 15, 2018
Actual Primary Completion Date
:
Feb 20, 2020
Actual Study Completion Date
:
Feb 20, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Passive Control 20 minute sedentary control period during which participants watched an emotionally neutral video. |
Drug: Placebo into the intranasal mucosa
6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
Other Names:
Drug: 20 IU NovoLog Insulin aspart into the intranasal mucosa
5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
Other Names:
Drug: 40 IU NovoLog Insulin aspart into the intranasal mucosa
4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
Other Names:
Drug: 60 IU NovoLog Insulin aspart into the intranasal mucosa
3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
Other Names:
Drug: 80 IU NovoLog Insulin aspart into the intranasal mucosa
2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
Other Names:
Drug: 100 IU NovoLog Insulin aspart into the intranasal mucosa
1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
Other Names:
Drug: 120 IU NovoLog Insulin aspart into the intranasal mucosa
6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
Other Names:
|
| Experimental: Acute Exercise 20 minute physical activity period during which participants exercised on a treadmill at an intensity corresponding to 60-65% of maximum heart rate while watching an emotionally neutral video. |
Drug: Placebo into the intranasal mucosa
6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
Other Names:
Drug: 20 IU NovoLog Insulin aspart into the intranasal mucosa
5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
Other Names:
Drug: 40 IU NovoLog Insulin aspart into the intranasal mucosa
4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
Other Names:
Drug: 60 IU NovoLog Insulin aspart into the intranasal mucosa
3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
Other Names:
Drug: 80 IU NovoLog Insulin aspart into the intranasal mucosa
2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
Other Names:
Drug: 100 IU NovoLog Insulin aspart into the intranasal mucosa
1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
Other Names:
Drug: 120 IU NovoLog Insulin aspart into the intranasal mucosa
6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol [During the 20 minute exercise/control period and the cognitive assessments.]
The manifestation of any symptom that could be associated with alterations in blood glucose and side effects of intranasal insulin. Fewer symptoms would indicate a better outcome. Burning/tingling of the nose and watering/tearing of the eyes during the nasal spray were the most cited symptoms.
- Number of Participants With Manifestation of Any Symptom Following the Protocol [Approximately 1 hour following the dose of intranasal insulin (~32 minutes following the end of the passive control/exercise condition; immediately following the completion of the post-test cognitive assessments)]
The manifestation of any symptom that could be associated with alterations in blood glucose and side effects of intranasal insulin. Fewer symptoms would indicate a better outcome. The most cited symptom was having a runny nose.
- Effect Size for Change in Behavioral Index of Inhibitory Control - RT [Prior to intranasal insulin administration relative to 30 minutes following]
The effect size of the change from pre-to-posttest in behavioral metrics of performance (RT) on a flanker test of inhibitory control. A more negative effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
- Effect Size for Change in Behavioral Index of Inhibitory Control - Accuracy [Prior to intranasal insulin administration relative to 30 minutes following]
The effect size of the change from pre-to-posttest in behavioral metrics of performance (response accuracy) on a flanker test of inhibitory control. A more positive effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
- Effect Size of Change in Neuroelectric Index of Attentional Engagement - Inhibition Task [Prior to intranasal insulin administration relative to 30 minutes following]
The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b amplitude) in response to the flanker test of inhibitory control. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A larger effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
- Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - Inhibition Task [Prior to intranasal insulin administration relative to 30 minutes following]
The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b latency) in response to the flanker test of inhibitory control. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A smaller effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
- Effect Size of Change in Behavioral Index of Sustained Attention - RT [Prior to intranasal insulin administration relative to 30 minutes following]
The effect size of the change from pre-to-posttest in behavioral metrics of performance (RT) on a Rapid Visual Information Processing test of sustained attention. A more negative effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
- Effect Size of Change in Behavioral Index of Sustained Attention - Accuracy [Prior to intranasal insulin administration relative to 30 minutes following]
The effect size of the change from pre-to-posttest in behavioral metrics of performance (response accuracy) on a Rapid Visual Information Processing test of sustained attention. A more positive effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
- Effect Size of Change in Neuroelectric Index of Attentional Engagement - RVIP Task [Prior to intranasal insulin administration relative to 30 minutes following]
The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b amplitude) in response to the target trial of the Rapid Visual Information Processing test of sustained attention. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A larger effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
- Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - RVIP Task [Prior to intranasal insulin administration relative to 30 minutes following]
The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b latency) in response to the target trial of the Rapid Visual Information Processing test of sustained attention. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A smaller effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Participants must be over the age of 18..
-
Participants must have normal or corrected-to-normal vision in order to complete the cognitive task.
Exclusion Criteria:
-
Lack of consent.
-
Presence of any major neurological health issues, brain trauma, or concussion with loss of consciousness assessed through a health history and demographics questionnaire.
-
Type I or Type II Diabetes
-
Self-reported pregnancy
-
Currently has any type of inflammation or blockage of the nasal passageways (i.e. allergies or a cold affecting the sinuses).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Kinesiology | East Lansing | Michigan | United States | 48824 |
Sponsors and Collaborators
- Michigan State University
Investigators
- Principal Investigator: Matthew B Pontifex, Ph.D., Michigan State University
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Matthew B. Pontifex, Ph.D.,
Associate Professor,
Michigan State University
ClinicalTrials.gov Identifier:
NCT04292535
Other Study ID Numbers:
- STUDY00000804
First Posted:
Mar 3, 2020
Last Update Posted:
Jun 21, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Matthew B. Pontifex, Ph.D.,
Associate Professor,
Michigan State University
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were recruited from the mid-Michigan area. |
|---|---|
| Pre-assignment Detail | 177 individuals were assessed for eligibility. 61 individuals were excluded (58 for failing medical screening, 1 diabetic, 1 unable to exercise, 1 history of epilepsy) 116 individuals were randomized using a serial stratification approach. |
| Arm/Group Title | Passive Control - Placebo | Passive Control - 20 IU | Passive Control - 40 IU | Passive Control - 60 IU | Passive Control - 80 IU | Passive Control - 100 IU | Passive Control - 120 IU | Acute Exercise - Placebo | Acute Exercise - 20 IU | Acute Exercise - 40 IU | Acute Exercise - 60 IU | Acute Exercise - 80 IU | Acute Exercise - 100 IU | Acute Exercise - 120 IU |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 20 minute sedentary control period during which participants watched an emotionally neutral video. Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer |
| Period Title: Overall Study | ||||||||||||||
| STARTED | 8 | 8 | 9 | 8 | 8 | 9 | 8 | 10 | 8 | 8 | 7 | 7 | 9 | 9 |
| COMPLETED | 8 | 8 | 9 | 8 | 8 | 9 | 8 | 8 | 8 | 8 | 7 | 6 | 8 | 7 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 1 | 1 | 2 |
Baseline Characteristics
| Arm/Group Title | Passive Control - Placebo | Passive Control - 20 IU | Passive Control - 40 IU | Passive Control - 60 IU | Passive Control - 80 IU | Passive Control - 100 IU | Passive Control - 120 IU | Acute Exercise - Placebo | Acute Exercise - 20 IU | Acute Exercise - 40 IU | Acute Exercise - 60 IU | Acute Exercise - 80 IU | Acute Exercise - 100 IU | Acute Exercise - 120 IU | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 20 minute sedentary control period during which participants watched an emotionally neutral video. Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | Total of all reporting groups |
| Overall Participants | 8 | 8 | 9 | 8 | 8 | 9 | 8 | 10 | 8 | 8 | 7 | 7 | 9 | 9 | 116 |
| Age (years) [Mean (Standard Deviation) ] | |||||||||||||||
| Mean (Standard Deviation) [years] |
20.8
(2.0)
|
20.7
(1.4)
|
20.0
(0.9)
|
21.9
(3.1)
|
19.6
(1.3)
|
20.8
(2.5)
|
23.1
(3.9)
|
19.8
(1.5)
|
19.9
(1.5)
|
21.8
(3.9)
|
21.3
(3.9)
|
20.2
(1.8)
|
20.1
(1.4)
|
20.1
(2.4)
|
20.7
(2.5)
|
| Sex: Female, Male (Count of Participants) | |||||||||||||||
| Female |
5
62.5%
|
5
62.5%
|
6
66.7%
|
5
62.5%
|
5
62.5%
|
6
66.7%
|
5
62.5%
|
6
60%
|
5
62.5%
|
5
62.5%
|
4
57.1%
|
4
57.1%
|
6
66.7%
|
5
55.6%
|
72
62.1%
|
| Male |
3
37.5%
|
3
37.5%
|
3
33.3%
|
3
37.5%
|
3
37.5%
|
3
33.3%
|
3
37.5%
|
4
40%
|
3
37.5%
|
3
37.5%
|
3
42.9%
|
3
42.9%
|
3
33.3%
|
4
44.4%
|
44
37.9%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||||||||||||
| Hispanic or Latino |
0
0%
|
2
25%
|
1
11.1%
|
0
0%
|
1
12.5%
|
1
11.1%
|
1
12.5%
|
0
0%
|
0
0%
|
1
12.5%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
7
6%
|
| Not Hispanic or Latino |
8
100%
|
6
75%
|
8
88.9%
|
8
100%
|
7
87.5%
|
8
88.9%
|
7
87.5%
|
10
100%
|
8
100%
|
7
87.5%
|
7
100%
|
7
100%
|
9
100%
|
9
100%
|
109
94%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||||||||||||||
| American Indian or Alaska Native |
0
0%
|
1
12.5%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
0.9%
|
| Asian |
0
0%
|
0
0%
|
1
11.1%
|
2
25%
|
0
0%
|
0
0%
|
1
12.5%
|
2
20%
|
1
12.5%
|
1
12.5%
|
0
0%
|
0
0%
|
0
0%
|
1
11.1%
|
9
7.8%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
12.5%
|
0
0%
|
0
0%
|
0
0%
|
1
12.5%
|
0
0%
|
0
0%
|
1
14.3%
|
0
0%
|
0
0%
|
3
2.6%
|
| White |
7
87.5%
|
7
87.5%
|
8
88.9%
|
5
62.5%
|
6
75%
|
9
100%
|
6
75%
|
8
80%
|
6
75%
|
6
75%
|
5
71.4%
|
6
85.7%
|
9
100%
|
8
88.9%
|
96
82.8%
|
| More than one race |
1
12.5%
|
0
0%
|
0
0%
|
1
12.5%
|
1
12.5%
|
0
0%
|
1
12.5%
|
0
0%
|
0
0%
|
1
12.5%
|
2
28.6%
|
0
0%
|
0
0%
|
0
0%
|
7
6%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (Count of Participants) | |||||||||||||||
| United States |
8
100%
|
8
100%
|
9
100%
|
8
100%
|
8
100%
|
9
100%
|
8
100%
|
10
100%
|
8
100%
|
8
100%
|
7
100%
|
7
100%
|
9
100%
|
9
100%
|
116
100%
|
| Education (years) [Mean (Standard Deviation) ] | |||||||||||||||
| Mean (Standard Deviation) [years] |
14.4
(1.9)
|
14.2
(1.3)
|
13.7
(1.2)
|
14.4
(2.8)
|
13.6
(2.7)
|
13.4
(2.3)
|
15.6
(2.6)
|
13.0
(1.1)
|
13.2
(1.9)
|
15.1
(3.4)
|
14.0
(2.8)
|
13.7
(2.1)
|
13.4
(1.4)
|
13.2
(1.9)
|
13.9
(2.2)
|
| WASI-II (IQ) (units on a scale) [Mean (Standard Deviation) ] | |||||||||||||||
| Mean (Standard Deviation) [units on a scale] |
104.7
(6.6)
|
105.0
(7.6)
|
98.3
(8.1)
|
110.0
(6.4)
|
113.6
(10.1)
|
120.6
(12.7)
|
110.7
(10.5)
|
104.4
(4.3)
|
110.8
(18.8)
|
107.7
(8.0)
|
110.8
(4.1)
|
103.5
(8.7)
|
108.2
(16.8)
|
101.2
(17.8)
|
107.5
(9.9)
|
| Fasting blood glucose (mg/dL) (mg/dL) [Mean (Standard Deviation) ] | |||||||||||||||
| Mean (Standard Deviation) [mg/dL] |
94.1
(6.9)
|
96.0
(10.3)
|
99.0
(9.3)
|
91.9
(3.5)
|
96.4
(6.5)
|
94.4
(9.4)
|
97.8
(7.3)
|
92.2
(9.4)
|
97.4
(7.9)
|
87.1
(9.6)
|
93.1
(9.3)
|
96.3
(7.3)
|
92.7
(9.6)
|
96.0
(9.5)
|
94.6
(8.6)
|
| Aerobic fitness percentile (percentile) [Mean (Standard Deviation) ] | |||||||||||||||
| Mean (Standard Deviation) [percentile] |
44.7
(28.8)
|
26.2
(10.7)
|
68.5
(12.9)
|
54.5
(24.0)
|
35.9
(23.1)
|
53.6
(36.3)
|
41.7
(26.9)
|
59.2
(26.9)
|
45.2
(23.7)
|
48.7
(34.5)
|
52.0
(28.5)
|
55.8
(23.2)
|
71.8
(23.2)
|
28.8
(10.0)
|
46.9
(24.8)
|
Outcome Measures
| Title | Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol |
|---|---|
| Description | The manifestation of any symptom that could be associated with alterations in blood glucose and side effects of intranasal insulin. Fewer symptoms would indicate a better outcome. Burning/tingling of the nose and watering/tearing of the eyes during the nasal spray were the most cited symptoms. |
| Time Frame | During the 20 minute exercise/control period and the cognitive assessments. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Passive Control - Placebo | Passive Control - 20 IU | Passive Control - 40 IU | Passive Control - 60 IU | Passive Control - 80 IU | Passive Control - 100 IU | Passive Control - 120 IU | Acute Exercise - Placebo | Acute Exercise - 20 IU | Acute Exercise - 40 IU | Acute Exercise - 60 IU | Acute Exercise - 80 IU | Acute Exercise - 100 IU | Acute Exercise - 120 IU |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 20 minute sedentary control period during which participants watched an emotionally neutral video. Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer |
| Measure Participants | 8 | 8 | 9 | 8 | 8 | 9 | 8 | 10 | 8 | 8 | 7 | 7 | 9 | 9 |
| Count of Participants [Participants] |
4
50%
|
6
75%
|
6
66.7%
|
4
50%
|
5
62.5%
|
9
100%
|
5
62.5%
|
2
20%
|
4
50%
|
3
37.5%
|
4
57.1%
|
4
57.1%
|
7
77.8%
|
9
100%
|
| Title | Number of Participants With Manifestation of Any Symptom Following the Protocol |
|---|---|
| Description | The manifestation of any symptom that could be associated with alterations in blood glucose and side effects of intranasal insulin. Fewer symptoms would indicate a better outcome. The most cited symptom was having a runny nose. |
| Time Frame | Approximately 1 hour following the dose of intranasal insulin (~32 minutes following the end of the passive control/exercise condition; immediately following the completion of the post-test cognitive assessments) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Passive Control - Placebo | Passive Control - 20 IU | Passive Control - 40 IU | Passive Control - 60 IU | Passive Control - 80 IU | Passive Control - 100 IU | Passive Control - 120 IU | Acute Exercise - Placebo | Acute Exercise - 20 IU | Acute Exercise - 40 IU | Acute Exercise - 60 IU | Acute Exercise - 80 IU | Acute Exercise - 100 IU | Acute Exercise - 120 IU |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 20 minute sedentary control period during which participants watched an emotionally neutral video. Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer |
| Measure Participants | 8 | 8 | 9 | 8 | 8 | 9 | 8 | 10 | 8 | 8 | 7 | 7 | 9 | 9 |
| Count of Participants [Participants] |
1
12.5%
|
2
25%
|
0
0%
|
2
25%
|
1
12.5%
|
4
44.4%
|
3
37.5%
|
0
0%
|
1
12.5%
|
2
25%
|
1
14.3%
|
0
0%
|
3
33.3%
|
2
22.2%
|
| Title | Effect Size for Change in Behavioral Index of Inhibitory Control - RT |
|---|---|
| Description | The effect size of the change from pre-to-posttest in behavioral metrics of performance (RT) on a flanker test of inhibitory control. A more negative effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups. |
| Time Frame | Prior to intranasal insulin administration relative to 30 minutes following |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Passive Control - Placebo | Passive Control - 20 IU | Passive Control - 40 IU | Passive Control - 60 IU | Passive Control - 80 IU | Passive Control - 100 IU | Passive Control - 120 IU | Acute Exercise - Placebo | Acute Exercise - 20 IU | Acute Exercise - 40 IU | Acute Exercise - 60 IU | Acute Exercise - 80 IU | Acute Exercise - 100 IU | Acute Exercise - 120 IU |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 20 minute sedentary control period during which participants watched an emotionally neutral video. Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer |
| Measure Participants | 8 | 8 | 9 | 8 | 8 | 9 | 8 | 8 | 8 | 8 | 7 | 7 | 8 | 7 |
| Mean (95% Confidence Interval) [cohens d] |
-0.04
|
-0.29
|
-0.54
|
-0.10
|
-0.42
|
-0.25
|
-0.10
|
-0.08
|
-0.20
|
-0.25
|
-0.33
|
-0.19
|
-0.27
|
-0.36
|
| Title | Effect Size for Change in Behavioral Index of Inhibitory Control - Accuracy |
|---|---|
| Description | The effect size of the change from pre-to-posttest in behavioral metrics of performance (response accuracy) on a flanker test of inhibitory control. A more positive effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups. |
| Time Frame | Prior to intranasal insulin administration relative to 30 minutes following |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Passive Control - Placebo | Passive Control - 20 IU | Passive Control - 40 IU | Passive Control - 60 IU | Passive Control - 80 IU | Passive Control - 100 IU | Passive Control - 120 IU | Acute Exercise - Placebo | Acute Exercise - 20 IU | Acute Exercise - 40 IU | Acute Exercise - 60 IU | Acute Exercise - 80 IU | Acute Exercise - 100 IU | Acute Exercise - 120 IU |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 20 minute sedentary control period during which participants watched an emotionally neutral video. Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer |
| Measure Participants | 8 | 8 | 9 | 8 | 8 | 9 | 8 | 8 | 8 | 8 | 7 | 7 | 8 | 7 |
| Mean (95% Confidence Interval) [cohens d] |
-0.03
|
0.16
|
-0.04
|
-0.19
|
-0.06
|
-0.14
|
-0.05
|
0.05
|
-0.26
|
-0.12
|
0.06
|
-0.01
|
0.01
|
-0.13
|
| Title | Effect Size of Change in Neuroelectric Index of Attentional Engagement - Inhibition Task |
|---|---|
| Description | The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b amplitude) in response to the flanker test of inhibitory control. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A larger effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups. |
| Time Frame | Prior to intranasal insulin administration relative to 30 minutes following |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Passive Control - Placebo | Passive Control - 20 IU | Passive Control - 40 IU | Passive Control - 60 IU | Passive Control - 80 IU | Passive Control - 100 IU | Passive Control - 120 IU | Acute Exercise - Placebo | Acute Exercise - 20 IU | Acute Exercise - 40 IU | Acute Exercise - 60 IU | Acute Exercise - 80 IU | Acute Exercise - 100 IU | Acute Exercise - 120 IU |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 20 minute sedentary control period during which participants watched an emotionally neutral video. Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer |
| Measure Participants | 8 | 8 | 9 | 8 | 8 | 9 | 8 | 8 | 8 | 8 | 7 | 6 | 8 | 7 |
| Mean (95% Confidence Interval) [cohens d] |
0.07
|
-0.08
|
-0.01
|
0.00
|
0.00
|
-0.06
|
0.00
|
0.00
|
0.00
|
-0.04
|
0.01
|
-0.03
|
0.00
|
0.15
|
| Title | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - Inhibition Task |
|---|---|
| Description | The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b latency) in response to the flanker test of inhibitory control. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A smaller effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups. |
| Time Frame | Prior to intranasal insulin administration relative to 30 minutes following |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Passive Control - Placebo | Passive Control - 20 IU | Passive Control - 40 IU | Passive Control - 60 IU | Passive Control - 80 IU | Passive Control - 100 IU | Passive Control - 120 IU | Acute Exercise - Placebo | Acute Exercise - 20 IU | Acute Exercise - 40 IU | Acute Exercise - 60 IU | Acute Exercise - 80 IU | Acute Exercise - 100 IU | Acute Exercise - 120 IU |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 20 minute sedentary control period during which participants watched an emotionally neutral video. Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer |
| Measure Participants | 8 | 8 | 9 | 8 | 8 | 9 | 8 | 8 | 8 | 8 | 7 | 6 | 8 | 7 |
| Mean (95% Confidence Interval) [cohens d] |
-0.22
|
-0.06
|
0.16
|
0.15
|
-0.42
|
0.06
|
-0.05
|
-0.21
|
-0.03
|
-0.25
|
-0.41
|
0.12
|
0.19
|
0.20
|
| Title | Effect Size of Change in Behavioral Index of Sustained Attention - RT |
|---|---|
| Description | The effect size of the change from pre-to-posttest in behavioral metrics of performance (RT) on a Rapid Visual Information Processing test of sustained attention. A more negative effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups. |
| Time Frame | Prior to intranasal insulin administration relative to 30 minutes following |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Passive Control - Placebo | Passive Control - 20 IU | Passive Control - 40 IU | Passive Control - 60 IU | Passive Control - 80 IU | Passive Control - 100 IU | Passive Control - 120 IU | Acute Exercise - Placebo | Acute Exercise - 20 IU | Acute Exercise - 40 IU | Acute Exercise - 60 IU | Acute Exercise - 80 IU | Acute Exercise - 100 IU | Acute Exercise - 120 IU |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 20 minute sedentary control period during which participants watched an emotionally neutral video. Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer |
| Measure Participants | 8 | 8 | 9 | 8 | 8 | 9 | 8 | 8 | 8 | 8 | 7 | 7 | 8 | 7 |
| Mean (95% Confidence Interval) [cohens d] |
-0.18
|
-0.16
|
-0.15
|
-0.24
|
-0.20
|
-0.22
|
-0.11
|
-0.16
|
-0.05
|
-0.16
|
-0.18
|
-0.09
|
-0.19
|
-0.16
|
| Title | Effect Size of Change in Behavioral Index of Sustained Attention - Accuracy |
|---|---|
| Description | The effect size of the change from pre-to-posttest in behavioral metrics of performance (response accuracy) on a Rapid Visual Information Processing test of sustained attention. A more positive effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups. |
| Time Frame | Prior to intranasal insulin administration relative to 30 minutes following |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Passive Control - Placebo | Passive Control - 20 IU | Passive Control - 40 IU | Passive Control - 60 IU | Passive Control - 80 IU | Passive Control - 100 IU | Passive Control - 120 IU | Acute Exercise - Placebo | Acute Exercise - 20 IU | Acute Exercise - 40 IU | Acute Exercise - 60 IU | Acute Exercise - 80 IU | Acute Exercise - 100 IU | Acute Exercise - 120 IU |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 20 minute sedentary control period during which participants watched an emotionally neutral video. Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer |
| Measure Participants | 8 | 8 | 9 | 8 | 8 | 9 | 8 | 8 | 8 | 8 | 7 | 7 | 8 | 7 |
| Mean (95% Confidence Interval) [cohens d] |
0.69
|
0.81
|
0.05
|
0.87
|
0.62
|
0.71
|
0.69
|
0.54
|
0.36
|
-0.21
|
0.78
|
0.43
|
0.90
|
0.60
|
| Title | Effect Size of Change in Neuroelectric Index of Attentional Engagement - RVIP Task |
|---|---|
| Description | The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b amplitude) in response to the target trial of the Rapid Visual Information Processing test of sustained attention. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A larger effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups. |
| Time Frame | Prior to intranasal insulin administration relative to 30 minutes following |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Passive Control - Placebo | Passive Control - 20 IU | Passive Control - 40 IU | Passive Control - 60 IU | Passive Control - 80 IU | Passive Control - 100 IU | Passive Control - 120 IU | Acute Exercise - Placebo | Acute Exercise - 20 IU | Acute Exercise - 40 IU | Acute Exercise - 60 IU | Acute Exercise - 80 IU | Acute Exercise - 100 IU | Acute Exercise - 120 IU |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 20 minute sedentary control period during which participants watched an emotionally neutral video. Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer |
| Measure Participants | 8 | 8 | 9 | 8 | 8 | 9 | 8 | 8 | 8 | 8 | 7 | 6 | 8 | 7 |
| Mean (95% Confidence Interval) [cohens d] |
-0.02
|
-0.09
|
0.04
|
0.23
|
0.02
|
0.16
|
0.08
|
0.03
|
0.02
|
0.02
|
0.18
|
0.04
|
-0.03
|
-0.06
|
| Title | Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - RVIP Task |
|---|---|
| Description | The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b latency) in response to the target trial of the Rapid Visual Information Processing test of sustained attention. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A smaller effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups. |
| Time Frame | Prior to intranasal insulin administration relative to 30 minutes following |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Passive Control - Placebo | Passive Control - 20 IU | Passive Control - 40 IU | Passive Control - 60 IU | Passive Control - 80 IU | Passive Control - 100 IU | Passive Control - 120 IU | Acute Exercise - Placebo | Acute Exercise - 20 IU | Acute Exercise - 40 IU | Acute Exercise - 60 IU | Acute Exercise - 80 IU | Acute Exercise - 100 IU | Acute Exercise - 120 IU |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 20 minute sedentary control period during which participants watched an emotionally neutral video. Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer |
| Measure Participants | 8 | 8 | 9 | 8 | 8 | 9 | 8 | 8 | 8 | 8 | 7 | 6 | 8 | 7 |
| Mean (95% Confidence Interval) [cohens d] |
0.08
|
-0.06
|
-0.08
|
-0.09
|
0.26
|
0.25
|
-0.10
|
-0.03
|
0.34
|
0.00
|
0.04
|
0.05
|
0.10
|
0.05
|
Adverse Events
| Time Frame | Only during the two 90 minute sessions. | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The clinicaltrials.gov definitions for adverse events was used. Indications of onset of an issue related to hypoglycemia were stopping criteria for the study protocol and are considered herein as Non serious adverse events. | |||||||||||||||||||||||||||
| Arm/Group Title | Passive Control - Placebo | Passive Control - 20 IU | Passive Control - 40 IU | Passive Control - 60 IU | Passive Control - 80 IU | Passive Control - 100 IU | Passive Control - 120 IU | Acute Exercise - Placebo | Acute Exercise - 20 IU | Acute Exercise - 40 IU | Acute Exercise - 60 IU | Acute Exercise - 80 IU | Acute Exercise - 100 IU | Acute Exercise - 120 IU | ||||||||||||||
| Arm/Group Description | 20 minute sedentary control period during which participants watched an emotionally neutral video. Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute sedentary control period during which participants watched an emotionally neutral video. 120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. Placebo into the intranasal mucosa: 6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 20 IU NovoLog Insulin aspart into the intranasal mucosa: 5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 40 IU NovoLog Insulin aspart into the intranasal mucosa: 4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 60 IU NovoLog Insulin aspart into the intranasal mucosa: 3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 80 IU NovoLog Insulin aspart into the intranasal mucosa: 2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 100 IU NovoLog Insulin aspart into the intranasal mucosa: 1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | 20 minute physical activity period during which participants exercised on a treadmill at 60-65% of maximum heart rate. 120 IU NovoLog Insulin aspart into the intranasal mucosa: 6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer | ||||||||||||||
All Cause Mortality |
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| Passive Control - Placebo | Passive Control - 20 IU | Passive Control - 40 IU | Passive Control - 60 IU | Passive Control - 80 IU | Passive Control - 100 IU | Passive Control - 120 IU | Acute Exercise - Placebo | Acute Exercise - 20 IU | Acute Exercise - 40 IU | Acute Exercise - 60 IU | Acute Exercise - 80 IU | Acute Exercise - 100 IU | Acute Exercise - 120 IU | |||||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/10 (0%) | 0/8 (0%) | 0/8 (0%) | 0/7 (0%) | 0/7 (0%) | 0/9 (0%) | 0/9 (0%) | ||||||||||||||
Serious Adverse Events |
||||||||||||||||||||||||||||
| Passive Control - Placebo | Passive Control - 20 IU | Passive Control - 40 IU | Passive Control - 60 IU | Passive Control - 80 IU | Passive Control - 100 IU | Passive Control - 120 IU | Acute Exercise - Placebo | Acute Exercise - 20 IU | Acute Exercise - 40 IU | Acute Exercise - 60 IU | Acute Exercise - 80 IU | Acute Exercise - 100 IU | Acute Exercise - 120 IU | |||||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/10 (0%) | 0/8 (0%) | 0/8 (0%) | 0/7 (0%) | 0/7 (0%) | 0/9 (0%) | 0/9 (0%) | ||||||||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||||||||||
| Passive Control - Placebo | Passive Control - 20 IU | Passive Control - 40 IU | Passive Control - 60 IU | Passive Control - 80 IU | Passive Control - 100 IU | Passive Control - 120 IU | Acute Exercise - Placebo | Acute Exercise - 20 IU | Acute Exercise - 40 IU | Acute Exercise - 60 IU | Acute Exercise - 80 IU | Acute Exercise - 100 IU | Acute Exercise - 120 IU | |||||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 1/10 (10%) | 0/8 (0%) | 0/8 (0%) | 0/7 (0%) | 0/7 (0%) | 1/9 (11.1%) | 2/9 (22.2%) | ||||||||||||||
| Metabolism and nutrition disorders | ||||||||||||||||||||||||||||
| Hypoglycemic event | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/9 (0%) | 0 | 0/8 (0%) | 0 | 1/10 (10%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/7 (0%) | 0 | 0/7 (0%) | 0 | 1/9 (11.1%) | 1 | 2/9 (22.2%) | 2 |
Limitations/Caveats
As the present investigation was a Phase II Clinical Trial, the research design was not sufficiently powered for hypothesis testing. Given the potential risk of combining exercise with intranasal insulin the present investigation utilized a sample of healthy, non-diabetic, fasted college-aged adults to limit the potential for a serious adverse event.
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Matthew B. Pontifex |
|---|---|
| Organization | Michigan State University |
| Phone | 517-432-5105 |
| pontifex@msu.edu |
Responsible Party:
Matthew B. Pontifex, Ph.D.,
Associate Professor,
Michigan State University
ClinicalTrials.gov Identifier:
NCT04292535
Other Study ID Numbers:
- STUDY00000804
First Posted:
Mar 3, 2020
Last Update Posted:
Jun 21, 2021
Last Verified:
May 1, 2021