Countermeasures to Circadian Misalignment (NCT04966351) | Clinical Trial Compass
RecruitingNot Applicable
Countermeasures to Circadian Misalignment
United States32 participantsStarted 2021-07-07
Plain-language summary
Insufficient sleep and circadian misalignment are independent risk factors for the development of obesity and diabetes, yet few strategies exist to counter metabolic impairments when these behaviors are unavoidable.
This project will examine whether avoiding food intake during the biological night can mitigate the impact of circadian misalignment on metabolic homeostasis in adults during simulated night shift work. Findings from this study could identify a translatable strategy to minimize metabolic diseases in populations that include anyone working nonstandard hours such as police, paramedics, firefighters, military personnel, pilots, doctors and nurses, truck drivers, and individuals with sleep disorders.
Who can participate
Age range
18 Years – 35 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
. 18-35 old; men and women; equal numbers of women and men will be included.
. Body Mass Index (BMI) between 20.0 and 24.9 ("normal" weight).
. Sleep/wake history: habitual sleep duration between 7-9.25 hours.
. Altitude history: Potential subjects must have lived at Denver altitude or higher for at least 3 months prior to inpatient stay.
Exclusion criteria
. Any clinically significant medical, psychiatric, or sleep disorder
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
Insulin sensitivity-derived from glucose tolerance test
Timeframe: Change to be assessed at Day 3, Day 5, Day 31, Day 33.
2
Muscle tissue lipids-assessed by lipidomic analyses
Timeframe: Change to be assessed at Day 3, Day 5, Day 31, Day 33.
. Use of prescribed medications/supplements/illicit drugs within one month prior to study
. History of shift work in year prior to study, or travel more than one time zone in three weeks prior to study. \[NOTE: Subjects can be studied at a later date.\]
. Women with history of prior gynecological pathology, \<1 year post-partum, breast-feeding and/or pregnant.
. Non-English speakers will be excluded, as we do not have access to a translator who could rely accurate information to the participant for the consent or throughout the study.