Home Sleep and Metabolism

Study Overview
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Brief Summary
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Bedtimes and wake-up times vary from person to person. The aim of this research is to examine the associations between sleep habits and metabolism in healthy people. In this study, the investigators will collect information on sleep-wake habits and how the body uses energy.

Official Title
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Home Sleep and Metabolism

Conditions
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Overweight, Sleep

Intervention / Treatment
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* Other: sleep


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sleep Arm 1<br>Sleep Arm 1 | Other: sleep<br> <br> |
| Active Comparator: Sleep Arm 2<br>Sleep Arm 2 | Other: sleep<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in insulin sensitivity (SI) | 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. | The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period. | 
| Change from Baseline in total energy expenditure | 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. | The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period. | 
| Change from Baseline in energy intake | 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. | The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period. | 
| Change from Baseline in beta-cell function | 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. | The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period. | 
| Change from Baseline in disposition index | 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. | The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in body weight | 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. | The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period. |