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; n=15) while the other half will be be instructed to maintain their current sleep habits (n=15).

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 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: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

Inclusion Criteria

• Sleep <7h/night
• Body mass index 25-50 kg/m2
• Altered glucose metabolism (any of the following) Fasting glucose 100-125 mg/dL or, 2-h plasma glucose 140-199 mg/dL during an oral glucose tolerance test (OGTT) or, HbA1c 5.7-6.4% or, homeostatic model assessment of insulin resistance (HOMA-IR) ≥2.0

Exclusion Criteria

• Sleep disorders

  1. moderate to severe sleep apnea (apnea-hypopnea index ≥15 events/hour)
  2. had ≥15 periodic limb movements per hour sleep [PLMS]
  3. narcolepsy or insomnia

• Perform shift work

• Excessive caffeine or alcohol consumption

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

• Liver disease other than metabolic dysfunction associated steatotic liver disease (MASLD)

• Prior bariatric surgery

• Pregnancy or breastfeeding

• Taking medications that can affect study outcomes (alter sleep duration or glucose metabolism)

• Tobacco or illicit drug use

• Perform intense exercise >70 min/wk or moderate exercise >150 min/week

• Excessive alcohol consumption (>21 units of alcohol per week for men and >14 units of alcohol per week for women)

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
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