Actively Recruiting
Biomarkers of Habitual Short Sleep and Related Cardiometabolic Risk in Adults with Overweight and Obesity
Led by University of Utah · Updated on 2024-12-20
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate how increasing time spent in bed affects plasma ceramides and insulin sensitivity in adults with overweight and obesity who usually sleep less than 6.5 hours per night. The trial involves a randomized controlled design to compare a sleep extension intervention with a healthy lifestyle control group. The goal is to understand the impact of sleep duration on metabolic and cardiometabolic risk factors in this population. Participants are randomly assigned to one of two groups for an 8-week intervention at home. The sleep extension group receives counseling and instructions to increase their time in bed by 2 hours per night, along with weekly sleep tips and monitoring using a wrist device and sleep logs. The control group receives general health information about diet and physical activity and maintains their usual sleep habits. Both groups have equal contact with the study team throughout the trial. Before the study, participants complete a clinical overnight sleep disorder screening and about one week of baseline sleep monitoring. During and after the intervention, researchers assess plasma ceramides and insulin sensitivity through laboratory visits. Additional measures include weekly sleep time and satisfaction, food intake timing, daytime alertness, body mass index, circadian phase, and cardiac event risk. Participation involves ongoing sleep tracking and several visits for detailed metabolic assessments, with the total study duration spanning baseline and intervention periods.
CONDITIONS
Brief 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 prior 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 shift work within the last year
- Weight change greater than 10% over the prior six months
- Enrollment in weight loss or physical activity programs like the Diabetes Prevention Program
- Current smoking
- Alcohol intake exceeding 14 drinks per week or 3 drinks per day
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for overnight sleep disorders screening
Duration - ~1 week
Participants complete approximately 1 week of ambulatory real-world sleep monitoring at home to establish baseline sleep patterns.
Continuous monitoring at home using an actiwatch wrist-device and daily electronic sleep logs
Duration - 8 weeks
Participants are randomized to either increase their nightly time in bed by 2 hours with weekly counseling or maintain habitual sleep habits for 8 weeks at home.
Weekly visits for counseling or contact with study team; continuous sleep monitoring at home
Duration - 1 to 2 days
Participants complete overnight laboratory visits to assess plasma ceramides and insulin sensitivity after the intervention segment.
1 to 2 in-person overnight visits
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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