Towards targeted dietary support for shift-workers with type 2 diabetes
- Conditions
- Nutritional, Metabolic, EndocrineType 2 diabetesType 2 diabetes mellitus
- Registration Number
- ISRCTN11764942
- Lead Sponsor
- King's College London
- Brief Summary
2021 Protocol article in https://doi.org/10.1111/dme.14714 (added 26/08/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37452826/ (added 20/07/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
Current participant inclusion criteria as of 27/01/2022:
1. Male and female
2. Aged between 18 and 60 years old
3. Type 2 diabetes diagnosed by healthcare professional
4. Diabetes should be managed only by lifestyle (diet, activity), or medications not associated with hypoglycemic risk (e.g. acarbose, metformin DPP4 inhibitors, SGLT2 inhibitors)
5. Currently work a rotating and/or mixed shift pattern that includes regular night shifts (a minimum of 4 nights per month) as well as other types of shifts (e.g., days, early, or late shifts). A night shift is defined as a period of work between 11 pm and 6 am. The monitoring period needs to include 3-night shifts (either arranged in 3 consecutive night shifts or 2 consecutive night shifts and another single night shift), another type of shift (for example, day or early shifts), and rest days
6. Work in a hospital or residential care setting - any job role. Healthcare sector employees represent one of the largest employers of night workers in the UK.
7. Not diagnosed with or currently requiring active treatment (e.g. chemotherapy, immunotherapy, or radiotherapy for cancer) for any of the following conditions: heart attack, stroke, angina, thrombosis, kidney disease, liver disease, cancer
8. No recent history (last 5 years) of excess alcohol intake or substance abuse
9. No recent weight change (lost or gained) by more than 3 kg/7 lb (in the last 2 months)
10. Not started new medication within the last 3 months likely to interfere with energy metabolism, appetite regulation, and hormonal balance, including anti-inflammatory drugs or steroids, antibiotics, androgens, phenytoin, erythromycin, or thyroid hormones
_____
Previous inclusion criteria as of 21/09/2021:
1. Male and female
2. Aged between 18 and 60 years old
3. Type 2 diabetes diagnosed by healthcare professional
4. Diabetes should be managed only by lifestyle (diet, activity), or medications not associated with hypoglycemic risk (e.g. acarbose, metformin DPP4 inhibitors, SGLT2 inhibitors)
5. Currently work a rotating and/or mixed shift pattern that includes regular night shifts (a minimum of 4 nights per month) as well as other types of shifts (e.g., days, early or late shifts). A night shift is defined as a period of work between 11 pm and 6 am. The monitoring period needs to include 3-night shifts (either arranged in 3 consecutive night shifts or 2 consecutive night shifts and another single night shift), another type of shift (for example, day or early shifts) and rest days
6. Work in a hospital or residential care setting - any job role. (Healthcare sector employees represent one of the largest employers of night workers in the UK.)
7. No history of heart attack, stroke, angina, thrombosis, liver or kidney diseases, chronic gastrointestinal disorder or cancer
8. No history of excess alcohol intake or substance abuse
9. No recent weight change (lost or gained) by more than 3 kg/7 lb (in the last 2 months)
10. Not started new medication within the last 3 months likely to interfere with energy metabolism, appetite regulation and hormonal balance, including anti-inflammat
1. Females, who are pregnant or intending to become pregnant, or currently breastfeeding
2. Taking medications associated with hypoglycaemia (e.g. insulin, sulphonylureas (such as glicazide or glimepiride)
3. No travel arrangements outside UK within the period of data collection - data needs to be collected across a persons typical working period
4. Not already participating in a clinical trial - as likely to influence behaviour and/or glucose variability
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method