Metabolic Effects of Sleep Extension in People With Obesity

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).

Study Overview

• Status: Completed
• Conditions: Obesity; Insulin Resistance
• Intervention / Treatment: Behavioral: Sleep extension

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Maintain their usual sleep patterns
Experimental: Sleep Extension; Extend sleep duration to >7h/night; 15 participants	Behavioral: Sleep extension; Extend time-in-bed by one hour

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin Sensitivity	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.	Change from baseline testing after 4-6 weeks of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hepatic Insulin Sensitivity Index	Calculated as the inverse of the product of plasma insulin concentration and endogenous glucose rate of appearance (Ra)/kgFFM during the basal period of the clamp procedure. Higher values indicate greater insulin sensitivity.	Change from baseline testing after 4-6 weeks of intervention
Adipose Tissue Insulin Sensitivity Index	Calculated as the reciprocal of the product of palmitate Ra/kgFFM and plasma insulin concentration during basal conditions. Higher values indicate greater insulin sensitivity.	Change from baseline testing after 4-6 weeks of intervention
Homeostatic Model Assessment of Insulin Resistance	The homeostasis model assessment of insulin resistance (HOMA-IR) was calculated by dividing the product of the plasma concentrations of insulin (in µU/mL) and glucose (in mmol/L) by 22.5. Higher values indicate greater insulin resistance.	Change from baseline testing after 4-6 weeks of intervention
24 Hour Glucose Area Under the Concentration Curve	Plasma metabolite concentrations will be evaluated over a 24 hour period	Change from baseline testing after 4-6 weeks of intervention
24 Hour Insulin Area Under the Concentration Curve	Plasma insulin concentrations evaluated over a 24 hour period	Change from baseline testing after 4-6 weeks of intervention
24 Hour Non-esterified Fatty Acids Area Under the Concentration Curve	Plasma metabolite concentrations will be evaluated over a 24 hour period	Change from baseline testing after 4-6 weeks of intervention
Body Mass	Measured using a body weight scale	Change from baseline testing after 4-6 weeks of intervention
Fat-free Mass	Body composition assessed using dual-energy x-ray absorptiometry (DXA)	Change from baseline testing after 4-6 weeks of intervention
Body Fat	Body composition assessed using dual-energy x-ray absorptiometry (DXA)	Change from baseline testing after 4-6 weeks of intervention
Liver Fat	Proton-density fat fraction of the whole liver assessed by using magnetic resonance imaging (MRI)	Change from baseline testing after 4-6 weeks of intervention
Fasting Glucose	Plasma glucose measured after an overnight fast	Change from baseline testing after 4-6 weeks of intervention
Daily Time in Bed	Assessed by using actigraphy over 7 days	Change from baseline testing after 4-6 weeks of intervention
Daily Total Sleep Time	Assessed by using actigraphy over 7 days	Change from baseline testing after 4-6 weeks of intervention
Stage N1 Sleep Time	Assessed by using inpatient polysomnography	Change from baseline testing after 4-6 weeks of intervention
Stage N2 Sleep Time	Assessed by using inpatient polysomnography	Change from baseline testing after 4-6 weeks of intervention
Stage N3 Sleep Time	Assessed by using inpatient polysomnography	Change from baseline testing after 4-6 weeks of intervention
Rapid Eye Movement (REM) Sleep Time	Assessed by using inpatient polysomnography	Change from baseline testing after 4-6 weeks of intervention

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2018
• Primary Completion (Actual): July 15, 2024
• Study Completion (Actual): July 30, 2024

Study Registration Dates

• First Submitted: June 28, 2018
• First Submitted That Met QC Criteria: July 11, 2018
• First Posted (Actual): July 23, 2018

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Hyperinsulinism; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Insulin Resistance
• Other Study ID Numbers: 201805183; R01DK115502 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No