OPTI-SHIFT: The Metabolic and Circadian Effects of Shift Work
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Shift workers Measurements repeated during a series of day shifts and during a series of night shifts |
Other: Exposure to shift work
Detailed questionnaire adapted from the Standard Shiftwork Index, measured at inclusion
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 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 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 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, thyroid-stimulating hormone measured by clinical chemistry (mIU/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]
Cortisol measured by clinical chemistry (nmol/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 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 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]
- 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]
- 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 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 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 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 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 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
Other Outcome Measures
- Difference in blood metabolomic parameters [Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months]
As measured by high-throughput mass spectrometry metabolomics, semi-quantitative identification of small metabolites involved in carbohydrate, fat, protein, and steroid metabolism
- Difference in lipid metabolism [Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months]
As measured by high-throughput mass spectrometry lipidomics
- Difference in the exposure to ambient light [Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months]
As measured by a wearable spectrometer
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Men and women
-
Age 20-50 years
-
Working ≥ 80% full-time equivalent over the previous month and during the study
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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)
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Planned to work at least 3 consecutive night shifts during the study preceded by at least a day off or day shift
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Planned to work at least 3 consecutive day shifts during the study
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Confident use of a smartphone compatible with the study application (iOS, Android) and able to regularly take pictures of consumed food/drinks
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Able to give a fully informed consent and follow the study procedures
Exclusion Criteria:
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Planned or current pregnancy during the study
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Menopausal women
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Major illness or hospitalization over the previous month
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Carries a pacemaker, pump or other medical device that can be disabled by a magnet
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Major mental illness
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Trip to a different time zone (≥ 2-hour time difference) over the previous month or planned during the study
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Enrolled in an interventional clinical trial (potentially interfering with the main outcomes) over the previous month or planned during the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Geneva University Hospitals | Geneva | Switzerland | 1211 |
Sponsors and Collaborators
- Tinh-Hai Collet, MD
Investigators
- Principal Investigator: Tinh-Hai Collet, MD, Geneva University Hospitals, Geneva
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-01088