Metabolic Effects of Sleep Extension in People With Obesity

Obesity Clinical Trial

Official title:

Metabolic Effects of Sleep Extension in People With Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03594994
• Other study ID #: 201805183
• Status: Recruiting
• Phase: N/A
• Start date: October 29, 2018
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: Washington University School of Medicine
• Contact: Study Coordinator
• Phone: 314-273-1882
• Email: bogerz[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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) while the other half will be be instructed to maintain their current sleep habits.

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 extension intervention in both the control and sleep extension groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Sleep <7h/night

• Body mass index 30-49.9 kg/m2

• Altered glucose metabolism (any of the following) Fasting glucose =100 mg/dL or, 2-h plasma glucose =140 mg/dL during an oral glucose tolerance test (OGTT) or, HbA1c =5.7% or, homeostatic model assessment of insulin resistance (HOMA-IR) =2.5

Exclusion Criteria:

• Sleep disorders

• Excessive caffeine or alcohol consumption

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

• Prior bariatric surgery

• Pregnancy

• Tobacco or illicit drug use

• Perform regular moderate or intense exercise

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity

Intervention

Behavioral:
• Sleep extension
Extend time-in-bed by one hour

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin Sensitivity	Whole-body insulin sensitivity during a hyperinsulinemic-euglycemic clamp	Change from baseline testing after 4-6 weeks of intervention
Secondary	24 hour metabolite concentrations	Plasma metabolite concentrations will be evaluated over a 24 hour period	Change from baseline testing after 4-6 weeks of intervention
Secondary	24 hour hormone concentrations	Plasma hormone concentrations will be evaluated over a 24 hour period	Change from baseline testing after 4-6 weeks of intervention
Secondary	24 hour cytokine concentrations	Plasma cytokine concentrations will be evaluated over a 24 hour period	Change from baseline testing after 4-6 weeks of intervention
Secondary	regulation of circadian rhythm	Expression of peripheral clock genes	Change from baseline testing after 4-6 weeks of intervention
Secondary	Body composition	Body composition will be assessed using dual-energy x-ray absorptiometry (DXA) and magnetic resonance scanning	Change from baseline testing after 4-6 weeks of intervention
Secondary	Sleep study	Sleep staging will be assessed during an inpatient sleep study	Change from baseline testing after 4-6 weeks of intervention