Shift-work DisorderMIDNIGHTNCT05962112
Metabolic Implications of Day and Night-shift Working on NHS Healthcare Staff
An observational study of Shift-work Disorder, run by University of Oxford at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Shift-work Disorder
- What is being tested?
- Metabolic investigations after night-shifts
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2022to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: • NHS worker with rotating night and day shift working patterns
Who may be able to join
- Male or female
- National Health Service (NHS) worker with rotating night and day shift working patterns
- Age 18-75 years
Who cannot join
- 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
Show all 10Show fewer
- Primary sleep disorder
- Current glucocorticoid use
- Current melatonin use
- Patients with known non-alcoholic steatohepatitis or advanced hepatic fibrosis/cirrhosis
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Oxford
Oxford
Jeremy W Tomlinson, MD PhD, 44(0)1865 857359, jeremy.tomlinson@ocdem.ox.ac.uk
Leanne Hodson, PhD, leanne.hodson@ocdem.ox.ac.uk
About this study
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
- Being tested
- Metabolic investigations after night-shifts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolic investigations after night-shiftsOther
Metabolic investigations after night-shifts
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Through study completion (average of 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Apr 2022
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shift-work DisorderStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962112
- Sponsor's protocol ID
- 306915
- Acronym
- MIDNIGHT
- Status last verified
- May 2023
- First submitted
- 23 May 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Implications of Day and Night-shift Working on NHS Healthcare Staff
- ClinicalTrials.gov ID
- NCT05962112
- Acronym / sponsor ID
- MIDNIGHT / 306915
- Conditions
- Shift-work Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- • NHS worker with rotating night and day shift working patterns
Key inclusion criteria (3 listed)
- Male or female
- National Health Service (NHS) worker with rotating night and day shift working patterns
- Age 18-75 years
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metabolic investigations after night-shiftsMetabolic investigations after night-shifts | Other | – |
Primary outcome
Change in percentage incorporation of 2H2 palmitate from 2H2O into very low density lipoprotein triglyceride (VLDL-TG) after night shifts compared to day-shifts
Time frame: Through study completion (average of 2 weeks)
Incorporation of 2H2 palmitate from 2H2O into very low density lipoprotein triglyceride (VLDL-TG) represents a marker of hepatic de novo lipogenesis
3 secondary outcomes
Change in hepatic and peripheral insulin sensitivity (measured by glucose metabolism during hyperinsulinaemic euglycaemic clamp procedure) after night shifts compared to day shifts
Time frame: Through study completion (average of 2 weeks)
Mean daily sleep onset, wake time, midpoint of sleep, and sleep efficiency
Time frame: Through study completion (average of 2 weeks)
Mean daily activity counts
Time frame: Through study completion (average of 2 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shift-work Disorder, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Marjot (07816566933, thomas.marjot@ndm.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in percentage incorporation of 2H2 palmitate from 2H2O into very low density lipoprotein triglyceride (VLDL-TG) after night shifts compared to day-shifts (time frame: Through study completion (average of 2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.