Impact of Circulating and Tissue-specific Lipids on Vascular Function and Insulin Sensitivity in Chronic Night Shift Workers
NCT ID: NCT06550115
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-03-01
2029-06-30
Brief Summary
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Detailed Description
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Data from the investigators and others demonstrate impaired vascular endothelial function and insulin sensitivity during circadian misalignment, two important risk factors for future development of CVD and T2D. Furthermore, the investigators published and unpublished data support that circadian misalignment increases circulating bioactive lipids known to associate with impaired endothelial function and insulin resistance. Indeed, shift workers also have elevated circulating lipids, though it is not known which specific lipids are elevated, and whether they are associated with impaired vascular function and/or insulin sensitivity. Using a circadian-based eating intervention (time-restricted eating; TRE), we can consistently reduce lipids in circulation, as well as reduce heart rate and blood pressure and improve glucose homeostasis.
Therefore, the overall objective for this project is to examine whether increased plasma lipids are a potential mechanism by which chronic circadian misalignment impairs cardiovascular and metabolic health with the long-term goal of identifying novel therapeutic targets to combat the risks for disease when circadian misalignment is unavoidable. The central hypothesis is that reducing plasma lipids in night shift workers via TRE will improve vascular function, insulin sensitivity and glucose homeostasis, and reduce muscle tissue lipid accumulation. To test the hypothesis, we will conduct a 12-week randomized crossover study in 50 non-rotating night shift workers (25Females/25Males; 18-65years) with existing cardiometabolic risk factors. At the end of each 4-week outpatient condition (TRE vs Control with an intervening 4-week washout period), we will conduct rigorous 3-day inpatient assessment to determine the impact of plasma lipid reduction via TRE in chronic night shift workers on 1) vascular function and blood pressure; and 2) whole body and muscle-specific insulin sensitivity, glucose homeostasis and muscle lipid accumulation.
Achievement of these aims will identify a potential mechanism by which circadian misalignment impairs vascular function and insulin sensitivity (elevated plasma lipids), as well as a non-pharmacological tool (TRE) that could be implemented to reduce cardiometabolic disease risk in populations at elevated risk, in 20% of the US workforce who work nonstandard hours including military personnel, police, paramedics, firefighters, pilots, medical doctors and nurses, as well as people with sleep and circadian disorders.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Control eating during overnight work shift
For 4 weeks, participants will eat during the biological night as is typically done in night shift workers.
Control eating
Night shift workers will participate in 4 weeks of Control eating across the daytime and nighttime hours while remaining awake during overnight work shifts.
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.
Time-restricted eating
Night shift workers will participate in 4 weeks of fasting during the biological nighttime while remaining awake during overnight work shifts.
Interventions
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Time-restricted eating
Night shift workers will participate in 4 weeks of fasting during the biological nighttime while remaining awake during overnight work shifts.
Control eating
Night shift workers will participate in 4 weeks of Control eating across the daytime and nighttime hours while remaining awake during overnight work shifts.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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University of Colorado, Denver
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Colorado State University
OTHER
Responsible Party
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Josiane Broussard
Associate Professor
Principal Investigators
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Josiane L Broussard, PhD
Role: PRINCIPAL_INVESTIGATOR
Colorado State University
Locations
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Colorado State University
Fort Collins, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Josiane Broussard's Bibliography
Other Identifiers
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3717
Identifier Type: -
Identifier Source: org_study_id