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

NCT ID: NCT05962112

Last Updated: 2023-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2024-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Shift-work Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Metabolic investigations after night-shifts

Metabolic investigations after night-shifts

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Oxford

Oxford, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Thomas Marjot

Role: CONTACT

07816566933

Facility Contacts

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Jeremy W Tomlinson, MD PhD

Role: primary

44(0)1865 857359

Leanne Hodson, PhD

Role: backup

Other Identifiers

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306915

Identifier Type: -

Identifier Source: org_study_id

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