Back to resultsHome Sleep and Metabolism
Primary Purpose
Overweight, Sleep
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
sleep
Sponsored by
About this trial
This is an interventional other trial for Overweight
Eligibility Criteria
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.
Sites / Locations
- University of Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Sleep Arm 1
Sleep Arm 2
Arm Description
Sleep Arm 1
Sleep Arm 2
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02253368
First Posted
September 24, 2014
Last Updated
February 3, 2021
Sponsor
University of Chicago
1. Study Identification
Unique Protocol Identification Number
NCT02253368
Brief Title
Home Sleep and Metabolism
Official Title
Home Sleep and Metabolism
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 2014 (Actual)
Primary Completion Date
February 2020 (Actual)
Study Completion Date
October 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Sleep
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sleep Arm 1
Arm Type
Active Comparator
Arm Description
Sleep Arm 1
Arm Title
Sleep Arm 2
Arm Type
Active Comparator
Arm Description
Sleep Arm 2
Intervention Type
Other
Intervention Name(s)
sleep
Primary Outcome Measure Information:
Title
Change from Baseline in insulin sensitivity (SI)
Description
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.
Time Frame
The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period.
Title
Change from Baseline in total energy expenditure
Description
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.
Time Frame
The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period.
Title
Change from Baseline in energy intake
Description
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.
Time Frame
The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period.
Title
Change from Baseline in beta-cell function
Description
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.
Time Frame
The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period.
Title
Change from Baseline in disposition index
Description
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.
Time Frame
The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period.
Secondary Outcome Measure Information:
Title
Change from Baseline in body weight
Description
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.
Time Frame
The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esra Tasali, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35129580
Citation
Tasali E, Wroblewski K, Kahn E, Kilkus J, Schoeller DA. Effect of Sleep Extension on Objectively Assessed Energy Intake Among Adults With Overweight in Real-life Settings: A Randomized Clinical Trial. JAMA Intern Med. 2022 Apr 1;182(4):365-374. doi: 10.1001/jamainternmed.2021.8098.
Results Reference
derived
Learn more about this trial
Home Sleep and Metabolism
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