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Effect of Sleep Extension on Ceramides in People with Overweight and Obesity

NCT06180837 · University of Utah
In plain English

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Official title
Biomarkers of Habitual Short Sleep and Related Cardiometabolic Risk
About this study
A randomized controlled trial with real-world sleep extension in adults with overweight and obesity who habitually obtain short sleep duration will be conducted. Group allocation will be 1:1 and research staff and participants will be blinded until the conclusion of the baseline segment. The sleep extension group will receive counseling and instruction to increase nightly time in bed by 2 hours per night. Participants randomized to control will maintain their habitual sleep habits in their home environment. The intervention segment will last 8 weeks regardless of group assignment. Both groups will have equal contact time with the study team. Prior to enrollment participants will complete a clinical overnight sleep disorders screening. Baseline consists of an \~1-week ambulatory real-world monitoring segment. Following baseline, participants will be randomized 1:1 to either the sleep extension or control group for 8 weeks at home (intervention segment). Throughout the study, sleep duration will be monitored using an actiwatch wrist-device and a daily electronic sleep log. Following the baseline and intervention segments participants will complete rigorous overnight laboratory visits to assess plasma ceramides (targeted metabolomics assay) and insulin sensitivity (hyperinsulinemic-euglycemic clamp).
Eligibility criteria
Inclusion Criteria: 1. Age: 18-45 years old; equal numbers of men and women 2. Body mass index (BMI): 27.5-34.9 kg/m2 3. Sleep Habits: habitual self-reported average total sleep time (TST) \<6.5 hours per night for prior 6 months Exclusion Criteria: 1. Clinically diagnosed sleep disorder or major psychiatric illness 2. Evidence of significant organ dysfunction or disease (e.g., heart disease, kidney disease) 3. Clinically diagnosed diabetes or fasting plasma glucose ≥126 mg/dL or HbA1c ≥6.5% 4. Use of prescription drugs or substances known to influence sleep or glucose metabolism, or anticoagulant medications. 5. Cancer that has been in remission less than 5 years 6. Pregnant/nursing, experiencing menopause or post-menopausal 7. Shift-work: current or history of within last year 8. Weight change: \>10% of body weight over prior six months 9. Current enrollment in weight loss or physical activity program like the Diabetes Prevention Program 10. Currently smoking 11. Alcohol intake\>14 drinks per week or \>3 drinks per day
Study design
Enrollment target: 70 participants
Allocation: randomized
Masking: double
Age groups: adult
Timeline
Starts: 2024-02-12
Estimated completion: 2028-01
Last updated: 2024-12-20
Interventions
Behavioral: Sleep Extension Intervention
Primary outcomes
  • Total Plasma Ceramides (Immediately after the intervention)
  • Insulin Sensitivity (Immediately after the intervention)
Sponsor
University of Utah · other
Contacts & investigators
ContactChristopher M Depner, PhD · contact · christopher.depner@utah.edu · 801-581-2275
All locations (1)
College of Health Research Complex--University of UtahRecruiting
Salt Lake City, Utah, United States
Effect of Sleep Extension on Ceramides in People with Overweight and Obesity · TrialPath