Sleep Extension or Regularity to Reduce Diabetes Risk (NCT06128265) | Clinical Trial Compass
CompletedNot Applicable
Sleep Extension or Regularity to Reduce Diabetes Risk
United States18 participantsStarted 2024-01-03
Plain-language summary
The goal of this study is to identify an intervention that improves sleep health and consequently metabolic health by examining whether sleep extension or enforced regularity in short sleepers will have beneficial effects on diabetes and obesity risk.
Who can participate
Age range
21 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* African American or Black men and women
* Age 21-50 years old
* Overweight (BMI greater than or equal 25 kg/m2 and less than 35 kg/m2)
* Self-reported short sleep (less than 7hrs/night, sleep between 22:00-08:00, and who indicate they could sleep more if they had the opportunity)
* No previously diagnosed sleep disorders (including obstructive sleep apnea (OSA))
* No existing diagnosis of diabetes
* No history of endocrine dysfunction
* No history of psychiatric, cardiovascular, or eating disorders, not having a gastro-intestinal disease that requires dietary adjustment,
* Currently taking no medications (excluding statins and birth control)
Exclusion Criteria:
* Drug and nicotine use
* Habitual alcohol use of more than 2 drinks per day
* Caffeine intake of more than 500 mg per day
* Subjects who participated in medically managed weight loss program within the past year
* Subjects who have undergone bariatric surgery,
* Subjects who have dietary restrictions,
* Subjects who worked night shifts, or crossed any time zones in the month prior to the study.
* Sleep-disordered breathing (apnea-hypopnea index\>15 events/hour) from an overnight at home sleep test (NOX)
* Peri- and post-menopausal women will not be included.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sleep Onset Time
Timeframe: Baseline to Day 24
2
Sleep Wake Time
Timeframe: Baseline to Day 24
3
Sleep Duration
Timeframe: Baseline to Day 24
4
Standard Deviation of the Sleep Midpoint
Timeframe: Baseline to Day 24
5
Sleep Efficiency
Timeframe: Baseline to Day 24
6
Change in Glucose Homeostasis After 24 Days
Timeframe: Baseline to Day 24
7
Primary Outcome 7A and B - CGM Glucose Variability Metrics (MAG and SD)