Clinical trial NCT05177965: The Metabolic and Circadian Effects of Shift Work
Official title: The Metabolic and Circadian Effects of Shift Work - An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shift Work Schedule
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Shift workers

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Difference in glucose excursion
timeFrame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
Secondary outcomes:
measure: Difference in fasting glucose
timeFrame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
measure: Difference in weight
timeFrame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
measure: Difference in waist circumference
timeFrame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
measure: Difference in lipid profile
timeFrame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
measure: Difference in blood hormonal profile
timeFrame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
measure: Difference in eating duration
timeFrame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
measure: Difference in nutrient intake
timeFrame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
measure: Difference in systolic and diastolic blood pressure
timeFrame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
measure: Difference in heart rate variability
timeFrame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
measure: Difference in physical activity
timeFrame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
measure: Difference in sleep/wake cycles
timeFrame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
measure: Difference in sleep quality
timeFrame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
measure: Difference in attention and sleepiness
timeFrame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
measure: Difference in well-being
timeFrame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
measure: Difference in mental health outcomes
timeFrame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
Other outcomes:
measure: Difference in blood metabolomic parameters
timeFrame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
measure: Difference in lipid metabolism
timeFrame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
measure: Difference in the exposure to ambient light
timeFrame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
measure: Difference in the core body temperature
timeFrame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
Study officials:
affiliation: Geneva University Hospitals, Geneva
name: Tinh-Hai Collet, MD
role: PRINCIPAL_INVESTIGATOR
References: