Home Sleep and Metabolism

Overweight Clinical Trial

Official title:

Home Sleep and Metabolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02253368
• Other study ID #: IRB14-0528
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: October 2020

Study information

• Verified date: February 2021
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: October 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Overweight
• Sleep

Intervention

Other:
• sleep

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in insulin sensitivity (SI)	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.	The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period.
Primary	Change from Baseline in total energy expenditure	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.	The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period.
Primary	Change from Baseline in energy intake	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.	The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period.
Primary	Change from Baseline in beta-cell function	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.	The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period.
Primary	Change from Baseline in disposition index	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.	The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period.
Secondary	Change from Baseline in body weight	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.	The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period.