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Home Sleep and Metabolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02253368
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : February 5, 2021
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Tracking Information
First Submitted Date  ICMJE September 24, 2014
First Posted Date  ICMJE October 1, 2014
Last Update Posted Date February 5, 2021
Actual Study Start Date  ICMJE November 2014
Actual Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2018)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 26, 2014)
  • Change from Baseline in insulin sensitivity (SI) [ Time Frame: Baseline and at 4-weeks (end of study) ]
    Insulin sensiitivty will be derived form minimal model analysis of mixed meal tolerance test
  • Change from Baseline in total energy expenditure [ Time Frame: Baseline and at 4-weeks (end of study) ]
    total energy expenditure will be derived form doubly labeled water method
  • Change from Baseline in energy intake [ Time Frame: Baseline and at 4-weeks (end of study) ]
    energy intake will be derived form doubly labeled water method, body composition analysis
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2018)
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Home Sleep and Metabolism
Official Title  ICMJE Home Sleep and Metabolism
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE
  • Overweight
  • Sleep
Intervention  ICMJE Other: sleep
Study Arms  ICMJE
  • Active Comparator: Sleep Arm 1
    Sleep Arm 1
    Intervention: Other: sleep
  • Active Comparator: Sleep Arm 2
    Sleep Arm 2
    Intervention: Other: sleep
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 26, 2014)
210
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2020
Actual Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02253368
Other Study ID Numbers  ICMJE IRB14-0528
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of Chicago
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Chicago
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Esra Tasali, MD University of Chicago
PRS Account University of Chicago
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP