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

NCT05962112 | Unknown

• 1 other identifier: 306915
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Shift-work Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

• Mean daily sleep onset, wake time, midpoint of sleep, and sleep efficiency

  Through study completion (average of 2 weeks)

• Mean daily activity counts

  Through study completion (average of 2 weeks)

Interventions

Metabolic investigations after night-shifts OTHER

Metabolic investigations after night-shifts

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

• NHS worker with rotating night and day shift working patterns

You may qualify if:

• Male or female
• National Health Service (NHS) worker with rotating night and day shift working patterns
• Age 18-75 years

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

University of Oxford

Oxford, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

Central Study Contacts

Thomas Marjot

CONTACT

07816566933; thomas.marjot@ndm.ox.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: July 27, 2023
• Study Start: April 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: August 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)