Metabolic Effects of Sleep Extension in People With Obesity

Not Applicable

Completed

• Conditions: Obesity; Insulin Resistance
• Interventions: Behavioral: Sleep extension

• Registration Number: NCT03594994
• Lead Sponsor: Washington University School of Medicine

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 by one hour (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.

Study Timeline

• Study First Submitted: 2018-06-28
• Study First Submitted QC: 2018-07-11
• Study First Posted: 2018-07-23
• Study Start: 2018-10-29
• Primary Completion: 2024-07-15
• Study Completion: 2024-07-30
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-25
• Last Update Posted: 2024-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Sleep <7h/night
• Body mass index 30-49.9 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep Extension	Sleep extension	Extend time-in-bed by one hour

Primary Outcome Measures

Name	Time	Method
Insulin Sensitivity	Change from baseline testing after 4-6 weeks of intervention	Whole-body insulin sensitivity during a hyperinsulinemic-euglycemic clamp

Secondary Outcome Measures

Name	Time	Method
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
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
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
regulation of circadian rhythm	Change from baseline testing after 4-6 weeks of intervention	Expression of peripheral clock genes
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
Sleep study	Change from baseline testing after 4-6 weeks of intervention	Sleep staging will be assessed during an inpatient sleep study

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States