Impact of Circulating and Tissue-specific Lipids on Vascular Function and Insulin Sensitivity in Chronic Night Shift Workers

Recruiting now · Not applicable

Conditions studied: Circadian Rhythm Sleep Disorder of Shift Work Type, Metabolic Disease, Insulin Sensitivity, Blood Pressure

In brief

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, the mechanism(s) by which shift work and associated circadian misalignment increase CVD and T2D risk are unknown. This project will examine whether elevated plasma lipids are a mechanism by which circadian misalignment impairs vascular function, insulin sensitivity, glucose homeostasis and muscle lipid accumulation, which could be targeted to prevent and treat cardiometabolic disease in people who chronically experience circadian misalignment, which includes more than 20% of the US workforce.

Key facts

Study ID

NCT06550115

Run by

Colorado State University

People needed

50

Starts

2024-03-01

Expected to finish

2029-06-01

Last updated by the study team

2025-12-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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);

You may not qualify if…

• 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.

Where it is running

• Colorado State University — Fort Collins, Colorado, United States (enrolling)

Full record on ClinicalTrials.gov

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