acEx: Exercise Training on Brain Insulin Responsiveness

Sponsor

University Hospital Tuebingen (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06039787

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The overarching goal of the current study is to investigate the effect of one acute bout of exercise on the brain insulin responsiveness in a cross-over study design. To this end, investigators will compare the effect of two single endurance exercise sessions with different intensities, namely moderate intensity continuous training (MICT) and high-intensity-interval-training (HIIT), which will be performed in a randomized order. This will be compared to a waiting control condition.

Condition or Disease	Intervention/Treatment	Phase
Insulin Resistance Obesity	Behavioral: single bout of moderate intensity continuous training (MICT) Behavioral: single bout of High Intensity Interval Training (HIIT) Behavioral: waiting control	N/A

Detailed Description

Investigate one acute bout of exercise on the brain insulin responsiveness using functional magnetic resonance imaging in combination with intranasal insulin in healthy participants of normal-weight and overweight/obesity. Two single endurance exercise sessions with different intensities will be evaluated, namely moderate intensity continuous training (MICT) and high-intensity interval training (HIIT). This will be compared to a waiting control condition. In a cross-over design, investigators will compare cerebral response from before to after intranasal insulin administration after a single bout of HIIT or MICT compared to a control condition without exercise. Cerebral response is defined as the cerebral blood flow and resting state functional connectivity in response to intranasal insulin. Secondary outcomes include changes in blood metabolites and proteins and changes in eating behavior.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

In a cross-over design, we will compare cerebral response from before to after intranasal insulin administration after a single bout of HIIT or MICT compared to a control condition without exercise.In a cross-over design, we will compare cerebral response from before to after intranasal insulin administration after a single bout of HIIT or MICT compared to a control condition without exercise.

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

Effects of One Exercise Training Session on Brain Insulin Responsiveness

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: moderate intensity continuous training	Behavioral: single bout of moderate intensity continuous training (MICT) the MICT consists of 60 min continuous cycling
Experimental: High-intensity interval training	Behavioral: single bout of High Intensity Interval Training (HIIT) HIIT consists of 10-min warm-up at the power output corresponding to 50% peak power output (PPO), 4 x 4-min intervals at a power output corresponding to 75% PPO with a 4-min active resting period at 30% PPO to recover
Placebo Comparator: Waiting condition	Behavioral: waiting control sitting in a waiting room for 60 min

Arm

Intervention/Treatment

Experimental: moderate intensity continuous training

Behavioral: single bout of moderate intensity continuous training (MICT)

the MICT consists of 60 min continuous cycling

Experimental: High-intensity interval training

Behavioral: single bout of High Intensity Interval Training (HIIT)

HIIT consists of 10-min warm-up at the power output corresponding to 50% peak power output (PPO), 4 x 4-min intervals at a power output corresponding to 75% PPO with a 4-min active resting period at 30% PPO to recover

Placebo Comparator: Waiting condition

Behavioral: waiting control

sitting in a waiting room for 60 min

Outcome Measures

Primary Outcome Measures

Cerebral response after intranasal insulin administration [1 hour after exercise or waiting control]
The resting-state cerebral response from before to after intranasal insulin administration after a single bout of HIIT or MICT exercise compared to a control condition without exercise (i.e., waiting control)

Secondary Outcome Measures

Task based brain activation after high-intensity-interval-training (HITT) or moderate intensity continuous training (MICT) compared to control condition [1 hour after exercise or waiting control]
Food cue reactivity after a single bout of HIIT or MICT exercise compared to a control condition without exercise (i.e., waiting control)
Subjective feeling of hunger and food craving [baseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting control]
Questionnaire assessment before and after exercise or waiting control.
Changes in Blood-brain barrier integrity [1 hour after exercise or waiting control]
Robust multiple echo-time arterial spin labelling based Blood Brain Barrier integrity measurements from before to after intranasal insulin administration after a single bout of HIIT or MICT exercise compared to a control condition without exercise (i.e., waiting control)
Performance during cognitive tasks [1 hour after exercise or waiting control]
Cambridge Cognition Tests Battery to assess memory and inhibitory control using the paired associates learning task, the pattern recognition memory task and the stop-signal reaction task.
Changes in exerkines from plasma samples [baseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting control]
Blood sampling at 5 time points before and after a single bout of HIIT or MICT exercise compared to a control condition without exercise (i.e., waiting control)
Change in incretins from plasma samples [baseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting control]
Blood sampling at 5 time points before and after a single bout of HIIT or MICT exercise compared to a control condition without exercise (i.e., waiting control)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Normal weight group: BMI between ≥ 19.5 to 24.5 kg/m2
Overweight/Obesity group: BMI between ≥ 27.5 to 39 kg/m2
Less than 150 min/week for moderate-intensity physical activity
Less than 75 min/week for Vigorous- intensity exercise (WHO recommendations for regular physical activity of adults)
Written consent to participate in the study
Written consent to be informed about incidental findings

Exclusion Criteria

Type 2 diabetes, cardiovascular diseases such as chronic heart failure, myocardial infarction, status post stroke
Limitations to participate in ergometer-based exercise (balance and coordination disorders, orthopedic problems, …)
Insufficient knowledge of the German language
Persons who cannot legally give consent
Pregnancy or lactation
History of severe mental or somatic disorders including neurological diseases (incl. epileptic seizures and migraines)
Taking psychotropic drugs
Taking medications that influence glucose metabolism
Regular use of analgesic drugs
Taking anticoagulant agents
Previous bariatric surgery
Acute infection within the last 4 weeks
Hemoglobin values less than 12g/dl for women, less than 14 g/dl for men
Other diseases that in the opinion of the investigator may jeopardize the success of the study or indicate a risk to the volunteer
Current participation in a lifestyle intervention study or a pharmaceutical study
Metal implants which cannot be removed as pacemakers, artificial heart valve, electrical devices as insulin pumps, large tattoos, retainer over more than 4 teeth, contraceptive coil, implanted magnetic metal parts as screws or plates after a surgery
Persons with claustrophobia
Temperature-sensitive person
Persons with tinnitus or increased sensitivity to loud sounds

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Clinic Tübingen, Department of Internal Medicine IV	Tübingen		Germany	72076

Sponsors and Collaborators

University Hospital Tuebingen

Investigators

Study Director: Andreas L. Birkenfeld, MD, Institute for Diabetes research and Metabolic Diseases at the University of Tubingen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital Tuebingen

ClinicalTrials.gov Identifier:

NCT06039787

Other Study ID Numbers:

226/2023BO2

First Posted:

Sep 15, 2023

Last Update Posted:

Sep 15, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital Tuebingen

Exercise

functional magnetic resonance imaging

Intranasal insulin

Additional relevant MeSH terms:

Insulin Resistance

Study Results

No Results Posted as of Sep 15, 2023