- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05177965
The Metabolic and Circadian Effects of Shift Work (OPTI-SHIFT)
November 14, 2025 updated by: Tinh-Hai Collet, MD
The Metabolic and Circadian Effects of Shift Work - An Observational Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
72
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Geneva, Switzerland, 1211
- Geneva University Hospitals
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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.
Eligibility Criteria
Ages Eligible for Study
20 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Shift workers
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Shift workers
Measurements repeated during a series of day shifts and during a series of night shifts
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Detailed questionnaire adapted from the Standard Shiftwork Index, measured at inclusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in glucose excursion
Time Frame: 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
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Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in fasting glucose
Time Frame: 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)
|
Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
|
|
Difference in weight
Time Frame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
|
Body weight (Kg)
|
Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
|
|
Difference in waist circumference
Time Frame: 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
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Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
|
|
Difference in lipid profile
Time Frame: 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)
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Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
|
|
Difference in blood hormonal profile
Time Frame: 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
|
Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
|
|
Difference in eating duration
Time Frame: 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
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Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
|
|
Difference in nutrient intake
Time Frame: 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
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Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
|
|
Difference in systolic and diastolic blood pressure
Time Frame: 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
|
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
Time Frame: 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
|
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
Time Frame: 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
|
Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
|
|
Difference in sleep/wake cycles
Time Frame: 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
|
Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
|
|
Difference in sleep quality
Time Frame: 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
|
Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
|
|
Difference in attention and sleepiness
Time Frame: 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
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Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
|
|
Difference in well-being
Time Frame: 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
|
Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
|
|
Difference in mental health outcomes
Time Frame: 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
|
Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in blood metabolomic parameters
Time Frame: 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
|
Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
|
|
Difference in lipid metabolism
Time Frame: 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
|
Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
|
|
Difference in the exposure to ambient light
Time Frame: 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 spectrometer and the light exposure behaviour assessment (LEBA) questionnaire
|
Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
|
|
Difference in the core body temperature
Time Frame: 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 skin temperature and heat transfer sensor
|
Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tinh-Hai Collet, MD, Geneva University Hospitals, Geneva
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 Major Dates
Study Start (Actual)
February 1, 2022
Primary Completion (Actual)
August 30, 2024
Study Completion (Actual)
August 30, 2024
Study Registration Dates
First Submitted
November 18, 2021
First Submitted That Met QC Criteria
December 15, 2021
First Posted (Actual)
January 5, 2022
Study Record Updates
Last Update Posted (Estimated)
November 18, 2025
Last Update Submitted That Met QC Criteria
November 14, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 2021-01088
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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-
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-
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