RecruitingNot applicable

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

Biomarkers of Habitual Short Sleep and Related Cardiometabolic Risk

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 45 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 8 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Following baseline, participants will be randomized 1:1 to either the sleep extension or control group for 8 weeks at home (intervention segment)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether spending 2 more hours in bed each night changes blood fats called ceramides and how well insulin controls blood sugar. It is for adults ages 18–45 with overweight or obesity who sleep less than 6.5 hours a night. People are assigned by chance to either spend more time in bed or get basic health tips.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18–45; the study seeks equal numbers of men and women.
  • Body mass index (BMI), a measure of weight compared with height, of 27.5–34.9.
  • Report sleeping less than 6.5 hours a night on average for the past 6 months.

Who can't join

  • A diagnosed sleep disorder, major mental illness, or serious organ problem, such as heart or kidney disease.
  • Diagnosed diabetes, fasting blood sugar of 126 mg/dL or higher, or HbA1c (a measure of average blood sugar) of 6.5% or higher.
  • Use of prescription drugs or substances that affect sleep or how the body handles blood sugar, or use of blood thinners.
  • Cancer that has been in remission (signs reduced or gone) for less than 5 years.
  • Pregnant, breastfeeding, going through menopause, or past menopause.
  • Shift work now or within the past year.
  • Weight change of more than 10% in the past 6 months, or currently in a weight-loss or physical activity program.
  • Currently smoking, or drinking more than 14 alcoholic drinks a week or more than 3 a day.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (1)

UT