Type 2 diabetes Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus
Conditions
Interventions
Current interventions as of 13/07/2021:
This is a mixed-methods study involving quantitative (objective, numeric) data collection on blood glucose, diet, sleep and physical activity (
Sponsors
King's College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 27/10/2020: During night, day and rest conditions: 1. Blood glucose variability measures (continuous glucose monitor): 1.1. Coefficient of variation 1.2. Mean amplitude of glycemic excursion (MAGE) 1.3. Time in target and time 2. Dietary measures (diet diary): 2.1. Eating patterns (temporal distribution energy and nutrient intake) 2.2. Food choices (food group and type of food) 3. Qualitative (semi-structured questionnaires): 3.1. Identifying the individual, socio-cultural and environmental factors influencing dietary behaviour Previous primary outcome measure: During night, day and rest conditions: 1. Blood glucose variability measures (continuous glucose monitor) 1.1. Coefficient of variation 1.2. Mean amplitude of glycemic excursion (MAGE) 1.3. Time in target and time 2. Dietary measures (diet diary) 2.1. Eating patterns (temporal distribution energy and nutrient intake) 2.2. Food choices (food group and type of food) 3. Sleep (sleep diary and activity monitor) 3.1. Sleep patterns 4. Physical activity (activity monitor) 4.1. Temporal physical activity patterns 5. Qualitative (semi-structured questionnaires): 5.1. Identifying the individual, socio-cultural and environmental factors influencing dietary behaviour | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures: During night, day and rest conditions: 1. Sleep (sleep diary and activity monitor): 1.1. Sleep patterns (time, duration, frequency) 2. Physical activity (activity monitor): 2.1. Temporal physical activity patterns (time, duration, intensity) Previous secondary outcome measures: There are no secondary outcome measures | — |
Countries
England, United Kingdom
Contacts
Public ContactRachel Gibson
Outcome results
None listed