NCT05177965

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 5, 2022

Completed
27 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

2.6 years

First QC Date

November 18, 2021

Last Update Submit

November 14, 2025

Conditions

Shift Work Schedule

Outcome Measures

Primary Outcomes (1)

  • Difference in glucose excursion

    As measured by Continuous Glucose Monitoring

    Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months

Secondary Outcomes (15)

  • 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

  • Difference in weight

    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

    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

    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

    Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months

  • +10 more secondary outcomes

Other Outcomes (4)

  • 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

  • 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

  • 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

  • +1 more other outcomes

Study Arms (1)

Shift workers

Measurements repeated during a series of day shifts and during a series of night shifts

Other: Exposure to shift work

Interventions

Exposure to shift workOTHER

Detailed questionnaire adapted from the Standard Shiftwork Index, measured at inclusion

Shift workers

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Shift workers

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneva University Hospitals

Geneva, 1211, Switzerland

Location

Related Publications (1)

  • Hartmeyer SL, Phillips NE, Jassil FC, Joris C, Dibner C, Collet TH, Andersen M. Multi-Wearable Approach for Monitoring Diurnal Light Exposure and Body Rhythms in Nightshift Workers. Acta Physiol (Oxf). 2025 Jul;241(7):e70069. doi: 10.1111/apha.70069.

    PMID: 40485643RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, plasma

Study Officials

  • Tinh-Hai Collet, MD

    Geneva University Hospitals, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 18, 2021

First Posted

January 5, 2022

Study Start

February 1, 2022

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

November 18, 2025

Record last verified: 2025-11

Locations

CH(1)