Metabolic Effects of Sleep Extension in People With Obesity

NCT ID: NCT03594994

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-29
• Study Completion Date: 2024-07-30

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.

Conditions

Insulin Resistance; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control

Maintain their usual sleep patterns

Group Type: NO_INTERVENTION

No interventions assigned to this group

Sleep Extension

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

Group Type: EXPERIMENTAL

Sleep extension

Intervention Type: BEHAVIORAL

Extend time-in-bed by one hour

Interventions

Sleep extension

Extend time-in-bed by one hour

Intervention Type: BEHAVIORAL

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

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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01DK115502

Identifier Type: NIH

Identifier Source: secondary_id

View Link

201805183

Identifier Type: -

Identifier Source: org_study_id