RECRUITING

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

Conditions

Circadian Rhythm Sleep Disorder of Shift Work Type Metabolic Disease Insulin Sensitivity Blood Pressure Shift work Sleep Blood sugar Metabolism Lipids

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-03-01

Study Completion:2029-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06550115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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);	* 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.

Inclusion Criteria

Exclusion Criteria

* 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);

* 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.

Contacts and Locations

Study Contact

Josiane L Broussard, PhD

CONTACT

9704913103

josiane.broussard@colostate.edu

Ellen Lyon, MS

CONTACT

9704913103

ellen.lyon@colostate.edu

Principal Investigator

Josiane L Broussard, PhD

PRINCIPAL_INVESTIGATOR

Colorado State University

Study Locations (Sites)

Colorado State University

Fort Collins, Colorado, 80523

United States

Collaborators and Investigators

Sponsor: Colorado State University

Josiane L Broussard, PhD, PRINCIPAL_INVESTIGATOR, Colorado State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-01

Study Completion Date2029-06

Study Record Updates

Study Start Date2024-03-01

Study Completion Date2029-06

Terms related to this study

Keywords Provided by Researchers

Shift work
Sleep
Blood sugar
Metabolism
Lipids
Blood pressure

Additional Relevant MeSH Terms

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