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 range18 Years – 35 Years
SexALL
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
✕. 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.
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.
✕. 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.