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

Part of paid clinical trials in Fort Collins, Colorado.

Sponsor
Colorado State University
Study ID
NCT06550115
Status
Recruiting
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Conditions

  • Blood Pressure
  • Circadian Rhythm Sleep Disorder of Shift Work Type
  • Insulin Sensitivity
  • Metabolic Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Time-restricted eating — BEHAVIORAL
    Night shift workers will participate in 4 weeks of fasting during the biological nighttime while remaining awake during overnight work shifts.
  • Control eating — BEHAVIORAL
    Night shift workers will participate in 4 weeks of Control eating across the daytime and nighttime hours while remaining awake during overnight work shifts.

Study Details

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 Dates

Start date
Mar 1, 2024
Status verified
Dec 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Control eating during overnight work shift
    For 4 weeks, participants will eat during the biological night as is typically done in night shift workers.
  • Experimental: Time-restricted eating during overnight work shift
    For 4 weeks, participants will refrain from eating during the biological night while maintaining the same sleep opportunity and daily energy intake and macronutrient distribution without changing 24h energy intake.

Primary Outcome Measure

Blood pressure via 24-hour assessments [ Time Frame: Collected during inpatient laboratory visit after 4 weeks of Control and TRE ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Colorado State UniversityFort CollinsColorado80523
Ellen Lyon, MS
[email protected]
970-491-3103
Josiane L Broussard, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Colorado State University· Fort Collins, CO

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