Home Sleep and Circadian Phase: Mediators of Diabetes Risk

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01786564
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Actual Duration (Months): 93.8
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if deficient sleep and/or disruption with the body's internal clock ("circadian rhythms") are associated with diabetes risk. This study is being done to look at the possible relationships between sleep and risk of diabetes by examining sleep in the home and diabetes risk in the laboratory.

Condition or Disease	Intervention/Treatment	Phase
Sleep Deprivation; Diabetes; Circadian Dysregulation

Study Design

• Study Type: Observational
• Actual Enrollment: 120 participants
• Observational Model: Ecologic or Community
• Time Perspective: Cross-Sectional
• Official Title: Home Sleep and Circadian Phase: Mediators of Diabetes Risk
• Actual Study Start Date: Dec 6, 2011
• Actual Primary Completion Date: Sep 30, 2019
• Actual Study Completion Date: Sep 30, 2019

Outcome Measures

Primary Outcome Measures

1. Oral Disposition Index [baseline]

   The oral disposition index is based on the glucose and insulin levels during the first 30 minutes of a frequently sampled 5-hour oral glucose tolerance test. It reflects the combination of insulin sensitivity and insulin release in response to the glucose challenge. Higher values suggest a greater response.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Ages 21-50 years

2. BMI <40 kg/m2.

3. No major illness.

4. No history of psychiatric, endocrine, cardiac or sleep disorders,

5. Premenopausal, non-pregnant women.

6. Those with dyslipidemia and hypertension will be included if these conditions are controlled by a stable treatment, such as lipid-lowering or antihypertensive medications (except beta blockers).

Exclusion criteria include:

1. Persons with diabetes.

2. Persons with diagnosed sleep disorders or apnea-hypopnea index>15.

3. History of cardiovascular event or disease (excluding controlled hypertension).

4. Major psychiatric disorder or other major illness.

5. Persons taking medications, including but not limited to antidepressants and hypnotics (but excluding lipid-lowering drugs and anti-hypertensive medications as mentioned above).

6. Persons regularly taking medication that affects melatonin such as beta blockers and exogenous melatonin.

7. Anyone who tests positive for common drugs of abuse.

8. People with color blindness.

9. People who have had Lasik eye surgery.

10. People who work night shifts.

11. Participants who travel across multiple time zones will be studied only after they have remained in the Central Time Zone (or Indiana) for one month prior to the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: Kristen Knuston, PhD, Northwestern University

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - May 24, 2018

More Information

Publications

None provided.

• Responsible Party: Kristen Knutson, Associate Professor, Northwestern University
• ClinicalTrials.gov Identifier: NCT01786564
• Other Study ID Numbers: STU00204605
• First Posted: Feb 8, 2013
• Last Update Posted: Nov 27, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kristen Knutson, Associate Professor, Northwestern University: diabetes; sleep
• Additional relevant MeSH terms: Sleep Deprivation; Chronobiology Disorders; Diabetes Mellitus

Study Results

Participant Flow

Pre-assignment Detail	Of 120 participants enrolled in the study, 56 were eligible, continued in the study and provided some data.

Arm/Group Title	Study Sample
Arm/Group Description	This is a cross-sectional study so there is only one group.
Period Title: Overall Study
STARTED	120
COMPLETED	56
NOT COMPLETED	64

Baseline Characteristics

Arm/Group Title	Study Sample
Arm/Group Description	This is a cross-sectional study so there is only one group.
Overall Participants	56
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	56 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30 (8.4)
Sex: Female, Male (Count of Participants)
Female	29 51.8%
Male	27 48.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	27 48.2%
White	29 51.8%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	56 100%
Body Mass Index (BMI), kg/m2 (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	27.7 (5.3)
Habitual Sleep Duration (hours) (minutes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [minutes]	402 (39)
Habitual sleep efficiency (% of sleep period sleeping) (percentage) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage]	90.8 (3.5)
Habitual sleep start time (clock time) (Hours after midnight) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Hours after midnight]	0.27 (1.51)
Duration of Stage 2 sleep (minutes) (Minutes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Minutes]	190.6 (77.4)
Duration of Stage 3 sleep (minutes) (Minutes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Minutes]	68.4 (30.7)
Duration of Rapid Eye Movement (REM) sleep (minutes) (Minutes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Minutes]	96.5 (49.1)
Fasting glucose levels (mg/dl) (mg/dl) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dl]	86.8 (6.3)
Estimated Insulin Resistance (HOMA index method) (None (Index)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [None (Index)]	1.75 (1.82)
Oral Disposition Index at 30 minutes (None (Index)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [None (Index)]	11.5 (12.7)

Outcome Measures

1. Primary Outcome

Title	Oral Disposition Index
Description	The oral disposition index is based on the glucose and insulin levels during the first 30 minutes of a frequently sampled 5-hour oral glucose tolerance test. It reflects the combination of insulin sensitivity and insulin release in response to the glucose challenge. Higher values suggest a greater response.
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

Three participants did not have adequate glucose and/or insulin values to calculate the disposition index.

Arm/Group Title	Study Sample
Arm/Group Description	This is a cross-sectional study so there is only one group.
Measure Participants	53
Mean (Standard Deviation) [None (Index)]	11.5 (12.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Study Sample
	Comments	The cross-sectional association between habitual sleep duration and oral disposition index was analyzed.
	Type of Statistical Test	Other
	Comments	This is cross-sectional analysis in a single group.
Statistical Test of Hypothesis	p-Value	.13
	Comments	Unadjusted association. A priori p value of .05 was selected for statistical significance.
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Regression Coefficient
	Estimated Value	-.075
	Confidence Interval	(2-Sided) 95%; -.173 to .023
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Study Sample
	Comments	The cross-sectional association between habitual sleep quality (sleep percentage) and oral disposition index was analyzed.
	Type of Statistical Test	Other
	Comments	This is cross-sectional analysis
Statistical Test of Hypothesis	p-Value	.83
	Comments	Unadjusted association. P value of .05 was selected a priori as statistical significance
	Method	Regression, Linear
	Comments	Unadjusted.
Method of Estimation	Estimation Parameter	Regression Coefficient
	Estimated Value	0.12
	Confidence Interval	(2-Sided) 95%; -0.95 to 1.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Study Sample
	Comments	The cross-sectional association between amount of Stage 3 sleep and oral disposition index was analyzed.
	Type of Statistical Test	Other
	Comments	This is cross-sectional analysis in a single group.
Statistical Test of Hypothesis	p-Value	.39
	Comments	Unadjusted association. A priori p value of .05 was selected for statistical significance.
	Method	Regression, Linear
	Comments	Unadjusted
Method of Estimation	Estimation Parameter	Regression Coefficient
	Estimated Value	-.05
	Confidence Interval	(2-Sided) 95%; -.166 to 0.66
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Study Sample
	Comments	The cross-sectional association between amount of REM sleep and oral disposition index was analyzed.
	Type of Statistical Test	Other
	Comments	Unadjusted association. P value of .05 was selected a priori as statistical significance
Statistical Test of Hypothesis	p-Value	.11
	Comments	Unadjusted association. P value of .05 was selected a priori as statistical significance
	Method	Regression, Linear
	Comments	Unadjusted association.
Method of Estimation	Estimation Parameter	Regression Coefficient
	Estimated Value	-.058
	Confidence Interval	(2-Sided) 95%; -.129 to .014
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	During study participation, approximately 2 weeks.
Adverse Event Reporting Description	Definitions do not differ.
Arm/Group Title	Study Sample
Arm/Group Description	This is a cross-sectional study so there is only one group.
All Cause Mortality
	Study Sample
	Affected / at Risk (%)	# Events
Total	0/56 (0%)
Serious Adverse Events
	Study Sample
	Affected / at Risk (%)	# Events
Total	0/56 (0%)
Other (Not Including Serious) Adverse Events
	Study Sample
	Affected / at Risk (%)	# Events
Total	0/56 (0%)

Limitations/Caveats

Study sample was lower than anticipated.

More Information

Certain Agreements

Principal Investigators are NOT 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.