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Home Sleep and Metabolism

Home Sleep and Metabolism

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02253368
Enrollment
210
Registered
2014-10-01
Start date
2014-11-30
Completion date
2020-10-31
Last updated
2021-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight, Sleep

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.

Interventions

OTHERsleep

Sponsors

University of Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline in insulin sensitivity (SI)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 expenditureThe 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 intakeThe 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 functionThe 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 indexThe 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

MeasureTime frameDescription
Change from Baseline in body weightThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026