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Metabolic Effects of Sleep Extension in People With Obesity

Primary Purpose

Insulin Resistance, Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep extension
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Insulin Resistance

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Washington University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Sleep Extension

Arm Description

Normal sleep habits < 6h

Extend time-in-bed to 8 hours

Outcomes

Primary Outcome Measures

Insulin Sensitivity
Whole-body insulin sensitivity during a hyperinsulinemic-euglycemic clamp

Secondary Outcome Measures

24 hour metabolite concentrations
Plasma metabolite concentrations will be evaluated over a 24 hour period
24 hour hormone concentrations
Plasma hormone concentrations will be evaluated over a 24 hour period
24 hour cytokine concentrations
Plasma cytokine concentrations will be evaluated over a 24 hour period
regulation of circadian rhythm
Expression of peripheral clock genes
Body composition
Body composition will be assessed using dual-energy x-ray absorptiometry (DXA) and magnetic resonance scanning
Sleep study
Sleep staging will be assessed during an inpatient sleep study

Full Information

First Posted
June 28, 2018
Last Updated
August 2, 2023
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03594994
Brief Title
Metabolic Effects of Sleep Extension in People With Obesity
Official Title
Metabolic Effects of Sleep Extension in People With Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 29, 2018 (Actual)
Primary Completion Date
May 15, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Normal sleep habits < 6h
Arm Title
Sleep Extension
Arm Type
Experimental
Arm Description
Extend time-in-bed to 8 hours
Intervention Type
Behavioral
Intervention Name(s)
Sleep extension
Intervention Description
Extend time-in-bed to 8 hours
Primary Outcome Measure Information:
Title
Insulin Sensitivity
Description
Whole-body insulin sensitivity during a hyperinsulinemic-euglycemic clamp
Time Frame
Change from baseline testing after 4-6 weeks of intervention
Secondary Outcome Measure Information:
Title
24 hour metabolite concentrations
Description
Plasma metabolite concentrations will be evaluated over a 24 hour period
Time Frame
Change from baseline testing after 4-6 weeks of intervention
Title
24 hour hormone concentrations
Description
Plasma hormone concentrations will be evaluated over a 24 hour period
Time Frame
Change from baseline testing after 4-6 weeks of intervention
Title
24 hour cytokine concentrations
Description
Plasma cytokine concentrations will be evaluated over a 24 hour period
Time Frame
Change from baseline testing after 4-6 weeks of intervention
Title
regulation of circadian rhythm
Description
Expression of peripheral clock genes
Time Frame
Change from baseline testing after 4-6 weeks of intervention
Title
Body composition
Description
Body composition will be assessed using dual-energy x-ray absorptiometry (DXA) and magnetic resonance scanning
Time Frame
Change from baseline testing after 4-6 weeks of intervention
Title
Sleep study
Description
Sleep staging will be assessed during an inpatient sleep study
Time Frame
Change from baseline testing after 4-6 weeks of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Coordinator
Phone
314-273-1882
Email
bogerz@wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph Beals
Phone
314-362-8199
Email
bealsjw@wustl.edu
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Coordinator
Phone
314-273-1882
Email
bogerz@wustl.edu
First Name & Middle Initial & Last Name & Degree
Joseph Beals
Phone
3143628199
Email
bealsjw@wustl.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Metabolic Effects of Sleep Extension in People With Obesity

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