Home Sleep and Metabolism
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ClinicalTrials.gov Identifier: NCT02253368 |
Recruitment Status :
Completed
First Posted : October 1, 2014
Last Update Posted : February 5, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Overweight Sleep | Other: sleep | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 210 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Other |
Official Title: | Home Sleep and Metabolism |
Actual Study Start Date : | November 2014 |
Actual Primary Completion Date : | February 2020 |
Actual Study Completion Date : | October 2020 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Sleep Arm 1
Sleep Arm 1
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Other: sleep |
Active Comparator: Sleep Arm 2
Sleep Arm 2
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Other: sleep |
- Change from Baseline in insulin sensitivity (SI) [ Time Frame: The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period. ]Insulin sensitivity will be derived from minimal model analysis of mixed meal tolerance test. The mixed meal tolerance test is performed at the end of the first 2-week period and at the end of the second 2-week period. For each subject, the change from the first 2-week period in insulin sensitivity will be calculated.
- Change from Baseline in total energy expenditure [ Time Frame: The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period. ]Total energy expenditure will be derived from doubly labeled water method. For each subject, total energy expenditure will be calculated during each 2-week period and then the change from the first 2-week period in total energy expenditure will be calculated.
- Change from Baseline in energy intake [ Time Frame: The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period. ]Energy intake will be derived from doubly labeled water method and body composition analysis. For each subject, energy intake will be calculated during each 2-week period and then the change from the first 2-week period in energy intake will be calculated.
- Change from Baseline in beta-cell function [ Time Frame: The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period. ]Beta cell function will be derived from minimal model analysis of mixed meal tolerance test. The mixed meal tolerance test is performed at the end of the first 2-week period and at the end of the second 2-week period. For each subject, the change from the first 2-week period in beta-cell function will be calculated.
- Change from Baseline in disposition index [ Time Frame: The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period. ]Disposition index will be derived from minimal model analysis of mixed meal tolerance test. The mixed meal tolerance test is performed at the end of the first 2-week period and at the end of the second 2-week period. For each subject, the change from the first 2-week period in disposition index will be calculated.
- Change from Baseline in body weight [ Time Frame: The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period. ]Weight will be derived from scale weight measurements. For each subject, their change in weight will be calculated during each period and then the change from the first 2-week period in body weight will be calculated.

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Ages Eligible for Study: | 21 Years to 40 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age: 21-40 years
- Body mass index: 25.0 to 29.9 kg/m2
- Average habitual sleep duration of 6.5 hours or less per night (as confirmed by actigraphy)
- stable sleep habits for the past 6 months
Exclusion Criteria:
- obstructive sleep apnea or history of any other sleep disorder
- night or rotating shift work (current or in the past 2 years)
- habitual daytime naps
- recent (< 4 week) travel across time zones
- extreme chronotypes
- any acute or chronic medical condition
- diabetes
- prior or current eating or psychiatric disorders
- claustrophobia
- irregular menstrual periods, menopause, pregnancy,
- alcohol abuse, excessive caffeine intake, smoking, illegal drug use
- subjects who are currently following a weight loss regimen or any other special diet or exercise programs
- subjects who have received iv or oral contrast in the past 2 weeks
- use of any prescription medication that can affect sleep or metabolism with the exception of antihypertensive and lipid lowering agents as follows. Subjects who are taking anti-hypertensive medication and/or lipid-lowering agents will be included only if they are well controlled and on a stable regimen (no change in medications in the previous 3 months). However, beta-blockers and thiazide diuretics will not be allowed, as these medications are known to affect insulin sensitivity. Women will be required to not be on hormone replacement therapy.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02253368
United States, Illinois | |
University of Chicago | |
Chicago, Illinois, United States, 60637 |
Principal Investigator: | Esra Tasali, MD | University of Chicago |
Responsible Party: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT02253368 |
Other Study ID Numbers: |
IRB14-0528 |
First Posted: | October 1, 2014 Key Record Dates |
Last Update Posted: | February 5, 2021 |
Last Verified: | February 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Overweight Body Weight |