Metabolic Effects of Sleep Extension in People With Obesity

Sponsor
Washington University School of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT03594994
Collaborator
(none)
40
1
2
56
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Study Details

Study Description

Brief Summary

This study is designed to determine the impact of extending sleep duration on glucose metabolism in people with obesity. Half of the participants will be instructed to increase their time-in-bed to 8 hours (sleep extension) while the other half will be be instructed to maintain their current sleep habits.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Sleep extension
N/A

Detailed Description

Restricting sleep is known to be detrimental to glucose metabolism in healthy adults. Obesity is a condition associated with both lower sleep duration and poor glucose tolerance. Therefore, increasing sleep duration is a potentially novel therapeutic strategy for improving glucose metabolism in this population. The investigators will assess this by determining insulin sensitivity during a hyperinsulinemic-euglycemic clamp before and after a sleep extension intervention in both the control and sleep extension groups.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Metabolic Effects of Sleep Extension in People With Obesity
Actual Study Start Date :
Oct 29, 2018
Anticipated Primary Completion Date :
May 15, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

Normal sleep habits < 6h

Experimental: Sleep Extension

Extend time-in-bed to 8 hours

Behavioral: Sleep extension
Extend time-in-bed to 8 hours

Outcome Measures

Primary Outcome Measures

  1. Insulin Sensitivity [Change from baseline testing after 4-6 weeks of intervention]

    Whole-body insulin sensitivity during a hyperinsulinemic-euglycemic clamp

Secondary Outcome Measures

  1. 24 hour metabolite concentrations [Change from baseline testing after 4-6 weeks of intervention]

    Plasma metabolite concentrations will be evaluated over a 24 hour period

  2. 24 hour hormone concentrations [Change from baseline testing after 4-6 weeks of intervention]

    Plasma hormone concentrations will be evaluated over a 24 hour period

  3. 24 hour cytokine concentrations [Change from baseline testing after 4-6 weeks of intervention]

    Plasma cytokine concentrations will be evaluated over a 24 hour period

  4. regulation of circadian rhythm [Change from baseline testing after 4-6 weeks of intervention]

    Expression of peripheral clock genes

  5. Body composition [Change from baseline testing after 4-6 weeks of intervention]

    Body composition will be assessed using dual-energy x-ray absorptiometry (DXA) and magnetic resonance scanning

  6. Sleep study [Change from baseline testing after 4-6 weeks of intervention]

    Sleep staging will be assessed during an inpatient sleep study

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Sleep <6h/night

  • Body mass index 30-45 kg/m2

  • Altered glucose metabolism (any of the following) Fasting glucose ≥100 mg/dL or, 2-h plasma glucose ≥140 mg/dL during an oral glucose tolerance test (OGTT) or, HbA1c ≥5.7% or, homeostatic model assessment of insulin resistance (HOMA-IR) ≥2.5

Exclusion Criteria:
  • Sleep disorders

  • Excessive caffeine or alcohol consumption

  • Significant organ dysfunction/disease (e.g. diabetes, kidney disease)

  • Prior bariatric surgery

  • Pregnancy

  • Tobacco or illicit drug use

  • Perform regular moderate or intense exercise

Contacts and Locations

Locations

Site City State Country Postal Code
1 Washington University School of Medicine Saint Louis Missouri United States 63110

Sponsors and Collaborators

  • Washington University School of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT03594994
Other Study ID Numbers:
  • 201805183
First Posted:
Jul 23, 2018
Last Update Posted:
Aug 23, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 23, 2022