Actively Recruiting
Effect of Sleep Extension on Plasma Ceramides and Insulin Sensitivity in Adults with Overweight and Obesity with Short Sleep Duration A Randomized Controlled Trial by University of Utah
Led by University of Utah · Updated on 2024-12-20
70
Participants Needed
1
Research Sites
202 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how increasing time in bed affects plasma ceramides and insulin sensitivity in adults with overweight and obesity who typically sleep less than 6.5 hours per night. This randomized controlled trial compares a sleep extension intervention to a healthy lifestyle control group. The study aims to understand the relationship between sleep duration, metabolism, and cardiometabolic risk factors. Participants will be randomly assigned to either the sleep extension group or the control group for an 8-week intervention period at home. The sleep extension group will receive counseling and guidance to increase their time in bed by 2 hours per night, with weekly sleep tips and scheduled bed and wake times tailored to their individual routines. The control group will maintain their usual sleep habits and receive basic health information on topics such as physical activity and nutrition. Both groups will have similar contact time with the study team throughout the study. Before starting, participants will undergo a clinical overnight sleep disorder screening and complete about one week of baseline sleep monitoring at home using an actiwatch wrist device and a daily electronic sleep log. After the baseline and 8-week intervention periods, participants will complete overnight laboratory visits to measure plasma ceramides through a targeted metabolomics assay and assess insulin sensitivity using a hyperinsulinemic-euglycemic clamp. These measures will evaluate changes immediately after the intervention.
CONDITIONS
Official Title
Effect of Sleep Extension on Ceramides in People with Overweight and Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 45 years old with equal numbers of men and women
- Body mass index (BMI) between 27.5 and 34.9 kg/m2
- Habitual self-reported average total sleep time less than 6.5 hours per night for the past 6 months
You will not qualify if you...
- Clinically diagnosed sleep disorder or major psychiatric illness
- Significant organ dysfunction or disease such as heart or kidney disease
- Diagnosed diabetes or fasting plasma glucose ≥126 mg/dL or HbA1c ≥6.5%
- Use of prescription drugs or substances affecting sleep or glucose metabolism, or anticoagulant medications
- Cancer in remission for less than 5 years
- Pregnant, nursing, experiencing menopause, or post-menopausal
- Current or recent (within last year) shift work
- Weight change greater than 10% in the past six months
- Currently enrolled in a weight loss or physical activity program like the Diabetes Prevention Program
- Current smoking
- Alcohol intake exceeding 14 drinks per week or more than 3 drinks per day
AI-Screening
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Trial Site Locations
Total: 1 location
1
College of Health Research Complex--University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
C
Christopher M Depner, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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