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RECRUITINGINTERVENTIONAL

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

Biomarkers of Habitual Short Sleep and Related Cardiometabolic Risk

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The overall goal is to determine how a sleep extension intervention (increasing time in bed) in individuals who maintain less than 6.5 hours sleep per night affects their plasma ceramides and insulin sensitivity. Participants will undergo a randomized controlled trial, with sleep extension (intervention) and healthy lifestyle (control) groups. The sleep extension is designed to increase participant's time in bed by 2 hours per night. Alternatively, the control group will receive basic health information (e.g., physical activity, goal setting, and nutrition when eating out).

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

BEHAVIORAL

Sleep Extension Intervention

Sleep extension-based intervention focused on increasing time spent in bed by 2 hours per night by directly scheduling assigned bed and waketimes based on participant's individual schedules. Participants will receive weekly sleep tips and counseling on improving their sleep duration.

Locations (1)

College of Health Research Complex--University of Utah
Salt Lake City, Utah, United States