Metabolic Effects of Sleep Extension in People With Obesity

NCT03594994 | Completed Results DMC

• 2 other identifiers: 201805183R01DK115502
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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).

Conditions

Insulin Resistance; Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Hepatic Insulin Sensitivity Index

  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

• 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

Study Arms (2)

Control

NO INTERVENTION

Maintain their usual sleep patterns

Sleep Extension

EXPERIMENTAL

Extend sleep duration to \>7h/night; 15 participants

Behavioral: Sleep extension

Interventions

Sleep extension BEHAVIORAL

Extend time-in-bed by one hour

Sleep Extension

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

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

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Insulin Resistance; Obesity

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Joseph Beals
• Organization: Washington University

bealsjw@wustl.edu

314-362-8199

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: July 23, 2018
• Study Start: October 29, 2018
• Primary Completion: July 15, 2024
• Study Completion: July 30, 2024
• Last Updated: December 11, 2025
• Results First Posted: December 11, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)