The Metabolic and Circadian Effects of Shift Work
- Conditions
- Shift Work Schedule
- Interventions
- Other: Exposure to shift work
- Registration Number
- NCT05177965
- Lead Sponsor
- Tinh-Hai Collet, MD
- Brief Summary
In an exploratory observational pilot study, the investigators will focus on the effects of short-term circadian misalignment induced by shift work on multidimensional measurements including glucose excursion, metabolic health, circadian rhythms (measured in vitro and in vivo), sleep/wake cycles and ambient light, eating and activity patterns, well-being and attention.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 72
- Men and women
- Age 20-50 years
- Working ≥ 80% full-time equivalent over the previous month and during the study
- Working night shifts (i.e. shifts that comprise working hours between 23h and 06h) in rotation with day shifts (i.e. shifts that comprise working hours between 06h and 20h)
- Planned to work at least 3 consecutive night shifts during the study preceded by at least a day off or day shift
- Planned to work at least 3 consecutive day shifts during the study
- Confident use of a smartphone compatible with the study application (iOS, Android) and able to regularly take pictures of consumed food/drinks
- Able to give a fully informed consent and follow the study procedures
- Planned or current pregnancy during the study
- Menopausal women
- Major illness or hospitalization over the previous month
- Carries a pacemaker, pump or other medical device that can be disabled by a magnet
- Major mental illness
- Trip to a different time zone (≥ 2-hour time difference) over the previous month or planned during the study
- Enrolled in an interventional clinical trial (potentially interfering with the main outcomes) over the previous month or planned during the study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Shift workers Exposure to shift work Measurements repeated during a series of day shifts and during a series of night shifts
- Primary Outcome Measures
Name Time Method Difference in glucose excursion Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months As measured by Continuous Glucose Monitoring
- Secondary Outcome Measures
Name Time Method Difference in fasting glucose Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months As measured by clinical chemistry (mmol/L)
Difference in eating duration Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months Time from the first to last caloric intake over a 24-hour period
Difference in systolic and diastolic blood pressure Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months As measured by blood pressure arm cuff
Difference in sleep quality Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months As measured by the Pittsburgh Sleep Quality Index (PSQI), score ranges from 0 to 21 points, 0 indicating no difficulty and 21 severe difficulties
Difference in lipid profile Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months Total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol measured by clinical chemistry (mmol/L)
Difference in blood hormonal profile Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months Insulin (mIU/L), thyroid-stimulating hormone (mIU/L), cortisol (nmol/L) measured by clinical chemistry
Difference in waist circumference Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months Waist circumference (cm) assessed with a measuring tape
Difference in weight Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months Body weight (Kg)
Difference in nutrient intake Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months Total calorie and macronutrient intake over a 24-hour period
Difference in sleep/wake cycles Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months As measured by actigraphy
Difference in heart rate variability Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months As measured by wearable sensor
Difference in physical activity Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months As measured by actigraphy and the International Physical Activity Questionnaire
Difference in well-being Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months As measured by the World Health Organization-5 questionnaire (WHO-5), score ranges from 0 to 25, 0 indicating worst possible and 25 best possible
Difference in attention and sleepiness Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months As measured by the Sustained Attention to Response Test
Difference in mental health outcomes Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months As measured by the Patient Health Questionnaire-9 (PHQ-9), score ranges from 0 to 27, 0 indicating no depression and 27 severe depression
Trial Locations
- Locations (1)
Geneva University Hospitals
🇨🇭Geneva, Switzerland