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

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.

Study Overview

• Status: Recruiting
• Conditions: Shift-work Disorder
• Intervention / Treatment: Other: Metabolic investigations after night-shifts

• Study Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

• Study Contact: Name: Thomas Marjot; Phone Number: 07816566933; Email: thomas.marjot@ndm.ox.ac.uk

Study Locations

• United Kingdom
  • Oxford, United Kingdom
    • Recruiting
    • University of Oxford
    • Contact: Jeremy W Tomlinson, MD PhD; Phone Number: 44(0)1865 857359; Email: jeremy.tomlinson@ocdem.ox.ac.uk
    • Contact: Leanne Hodson, PhD; Email: leanne.hodson@ocdem.ox.ac.uk
    • Sub-Investigator: Thomas Marjot, MD
    • Sub-Investigator: Leanne Hodson, MD
    • Sub-Investigator: David Ray, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

• NHS worker with rotating night and day shift working patterns

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Measured by continuous actigraphy during night- compared to day-shifts night-shifts	Through study completion (average of 2 weeks)
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)

Collaborators and Investigators

• Sponsor: University of Oxford

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: July 18, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 306915

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No