Status:
RECRUITING
Impact of Circulating and Tissue-specific Lipids on Vascular Function and Insulin Sensitivity in Chronic Night Shift Workers
Lead Sponsor:
Colorado State University
Collaborating Sponsors:
University of Colorado, Denver
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Circadian Rhythm Sleep Disorder of Shift Work Type
Metabolic Disease
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
People who experience repeated bouts of circadian misalignment, such as shift workers, are at higher risk of cardiovascular disease (CVD) and Type 2 diabetes (T2D) compared to daytime workers. However...
Detailed Description
There is growing recognition that timing of behaviors, such as eating, sleeping, and activity, have a significant impact on human health and disease risk. For example, when people are awake at the "wr...
Eligibility Criteria
Inclusion
- 18-65 years old
- worked the night shift for the last 1 year or more,
- habitually sleep 5-9 hours per 24h period (night shift workers typically experience chronic insufficient sleep),
- body mass index (BMI) of 20.0 - 35.0 kg/m2 and weight stable (plus or minus 5% of current body weight in the last 6 months); sedentary to mild physical activity level (less than 2 days of planned exercise per week);
Exclusion
- existing diagnosed sleep or eating disorder (e.g. obstructive sleep apnea \[OSA\], periodic limb movements of sleep \[PLMS\], narcolepsy, travel more than 1 time zone in 3 weeks before the study; anorexia nervosa, more than one food allergy to maintain flexibility in diet planning);
- following any TRE (time-restricted eating) or intermittent fasting plan in the last year;
- following any special diet plan, like paleo, keto, gluten-free or vegan, that can affect the primary lipid outcome measures in the last 6 months; any clinically significant surgical condition within the last year;
- diagnosed diabetes or cardiovascular disease
- The prevalence of insomnia in shift workers is fairly high, ranging from 12.8% to 76.4%, which is higher than estimated for the general population. Insomnia itself is associated with elevated neural cardiovascular responsiveness to stress compared to people without insomnia. Thus, since excessive sleepiness and symptoms of insomnia may be present in night shift workers they will not be exclusionary.
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06550115
Start Date
March 1 2024
End Date
June 1 2029
Last Update
December 17 2025
Active Locations (1)
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1
Colorado State University
Fort Collins, Colorado, United States, 80523