Skip to main content
Clinical Trials/NCT03594994
NCT03594994
Completed
Not Applicable

Metabolic Effects of Sleep Extension in People With Obesity

Washington University School of Medicine1 site in 1 country31 target enrollmentOctober 29, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Insulin Resistance
Sponsor
Washington University School of Medicine
Enrollment
31
Locations
1
Primary Endpoint
Insulin Sensitivity
Status
Completed
Last Updated
4 months ago

Overview

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 in order to achieve >7h sleep/night (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.

Registry
clinicaltrials.gov
Start Date
October 29, 2018
End Date
July 30, 2024
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • moderate to severe sleep apnea (apnea-hypopnea index ≥15 events/hour)
  • had ≥15 periodic limb movements per hour sleep \[PLMS\]
  • 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

Outcomes

Primary Outcomes

Insulin Sensitivity

Time Frame: Change from baseline testing after 4-6 weeks of intervention

Whole-body insulin sensitivity calculated as the insulin stimulated rate of glucose disposal per kilogram of fat-free body mass (µmol/kgFFM/min) during a hyperinsulinemic-euglycemic clamp.

Secondary Outcomes

  • 24 Hour Glucose Area Under the Concentration Curve(Change from baseline testing after 4-6 weeks of intervention)
  • 24 Hour Insulin Area Under the Concentration Curve(Change from baseline testing after 4-6 weeks of intervention)
  • 24 Hour Non-esterified Fatty Acids Area Under the Concentration Curve(Change from baseline testing after 4-6 weeks of intervention)
  • Fasting Glucose(Change from baseline testing after 4-6 weeks of intervention)
  • Daily Time in Bed(Change from baseline testing after 4-6 weeks of intervention)
  • Hepatic Insulin Sensitivity Index(Change from baseline testing after 4-6 weeks of intervention)
  • Daily Total Sleep Time(Change from baseline testing after 4-6 weeks of intervention)
  • Stage N1 Sleep Time(Change from baseline testing after 4-6 weeks of intervention)
  • Stage N2 Sleep Time(Change from baseline testing after 4-6 weeks of intervention)
  • Stage N3 Sleep Time(Change from baseline testing after 4-6 weeks of intervention)
  • Rapid Eye Movement (REM) Sleep Time(Change from baseline testing after 4-6 weeks of intervention)
  • Adipose Tissue Insulin Sensitivity Index(Change from baseline testing after 4-6 weeks of intervention)
  • Homeostatic Model Assessment of Insulin Resistance(Change from baseline testing after 4-6 weeks of intervention)
  • Body Mass(Change from baseline testing after 4-6 weeks of intervention)
  • Liver Fat(Change from baseline testing after 4-6 weeks of intervention)
  • Fat-free Mass(Change from baseline testing after 4-6 weeks of intervention)
  • Body Fat(Change from baseline testing after 4-6 weeks of intervention)

Study Sites (1)

Loading locations...

Similar Trials