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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 : Active, not recruiting
First Posted : October 1, 2014
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Description
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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.

Condition or disease Intervention/treatment Phase
Overweight Sleep Other: sleep Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 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
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Sleep Arm 1
Sleep Arm 1
 Other: sleep
Active Comparator: Sleep Arm 2
Sleep Arm 2
 Other: sleep


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Esra Tasali, MD University of Chicago
  Study Documents (Full-Text)

Documents provided by University of Chicago:
Informed Consent Form  [PDF] June 18, 2019

More Information
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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: May 29, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms