Home Sleep and Metabolism

• ClinicalTrials.gov Identifier: NCT02253368
• Recruitment Status: Completed
• First Posted: October 1, 2014
• Last Update Posted: February 5, 2021
• Sponsor: University of Chicago
• Information provided by (Responsible Party): University of Chicago

Tracking Information

• First Submitted Date: September 24, 2014
• First Posted Date: October 1, 2014
• Last Update Posted Date: February 5, 2021
• Actual Study Start Date: November 2014
• Actual Primary Completion Date: February 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Home Sleep and Metabolism
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Other

Condition

• Overweight
• Sleep

• Intervention: Other: sleep

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 26, 2014): 210
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 2020
• Actual Primary Completion Date: February 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02253368
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: University of Chicago
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Chicago
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Esra Tasali, MD; University of Chicago

• PRS Account: University of Chicago
• Verification Date: February 2021