NCT02253368

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 1, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

February 5, 2021

Status Verified

February 1, 2021

Enrollment Period

5.3 years

First QC Date

September 24, 2014

Last Update Submit

February 3, 2021

Conditions

OverweightSleep

Outcome Measures

Primary Outcomes (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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 Outcomes (1)

  • Change from Baseline in body weight

    The entire 4-week study is comprised of two 2-week periods: first 2-week period (baseline) and second 2-week period.

Study Arms (2)

Sleep Arm 1

ACTIVE COMPARATOR

Sleep Arm 1

Other: sleep

Sleep Arm 2

ACTIVE COMPARATOR

Sleep Arm 2

Other: sleep

Interventions

sleepOTHER
Sleep Arm 1Sleep Arm 2

Eligibility Criteria

Age21 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

  • 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.

    PMID: 35129580DERIVED

MeSH Terms

Conditions

Overweight

Interventions

Sleep

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Esra Tasali, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2014

First Posted

October 1, 2014

Study Start

November 1, 2014

Primary Completion

February 1, 2020

Study Completion

October 1, 2020

Last Updated

February 5, 2021

Record last verified: 2021-02

Locations

US(1)