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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05962112
Other study ID # 306915
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2022
Est. completion date April 1, 2024

Study information

Verified date May 2023
Source University of Oxford
Contact Thomas Marjot
Phone 07816566933
Email thomas.marjot@ndm.ox.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators will conduct an open label, experimental medicine study exploring the acute metabolic impact of night-shift compared to day-shift work in NHS healthcare workers. Employees who are scheduled to work both day and night shifts will be recruited and identical metabolic investigations will be performed in the same participant following at least 3 consecutive day and night-shifts respectively. These investigations will take place at the Clinical Research Unit (CRU) in Oxford Centre for Diabetes, Endocrinology and Metabolism (OCDEM) at Churchill Hospital. The order of post-day and post-night shift investigations will be randomly determined and there will be a 2-week minimum interval between both sets of investigations. Participants will complete a self-reported food diary before and during each set of shifts (both day and night) and will have wrist-watch actigraphy performed throughout the entire study period in order to measure sleep and activity parameters. All study visits and investigations will commence at the CRU at 8am and will include a 2-step hyperinsulinaemic euglycaemic clamp with stable isotope infusions.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date April 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Male or female - National Health Service (NHS) worker with rotating night and day shift working patterns - Age 18-75 years Exclusion Criteria: - A diagnosis of type 1 or type 2 diabetes - Pregnancy - A blood haemoglobin <120mg/dL - History of alcohol use disorder or a greater than recommended alcohol intake (Recommendations > 21 units on average per week for men and > 14 units on average per week for women) - Other conditions or co-morbidities that in the eyes of the investigators may affect data collection - Any condition in the opinion of the investigator that might impact upon safety or validity of the results - Primary sleep disorder - Current glucocorticoid use - Current melatonin use - Patients with known non-alcoholic steatohepatitis or advanced hepatic fibrosis/cirrhosis

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Metabolic investigations after night-shifts
Metabolic investigations after night-shifts

Locations

Country Name City State
United Kingdom University of Oxford Oxford

Sponsors (1)

Lead Sponsor Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in percentage incorporation of 2H2 palmitate from 2H2O into very low density lipoprotein triglyceride (VLDL-TG) after night shifts compared to day-shifts Incorporation of 2H2 palmitate from 2H2O into very low density lipoprotein triglyceride (VLDL-TG) represents a marker of hepatic de novo lipogenesis Through study completion (average of 2 weeks)
Secondary Change in hepatic and peripheral insulin sensitivity (measured by glucose metabolism during hyperinsulinaemic euglycaemic clamp procedure) after night shifts compared to day shifts Through study completion (average of 2 weeks)
Secondary Mean daily sleep onset, wake time, midpoint of sleep, and sleep efficiency Measured by continuous actigraphy during night- compared to day-shifts night-shifts Through study completion (average of 2 weeks)
Secondary Mean daily activity counts Measured by continuous wrist watch accelerometry during night- compared to day-shifts night-shifts Through study completion (average of 2 weeks)
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