Metabolic Implications of Day and Night-shift Working on NHS Healthcare Staff

Shift-work Disorder Clinical Trial

— MIDNIGHT  

Official title:

Metabolic Implications of Day and Night-shift Working on NHS Healthcare Staff

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05962112
• Other study ID #: 306915
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Shift-work Disorder

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)