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Completed

NCT Number: NCT02253368

Home Sleep and Metabolism

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep

Age range

21 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sleep

Other

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Oct 1, 2014
Registry last updated
Feb 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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