Dietary Approaches to the Management Of type 2 Diabetes – feasibility study
- Conditions
- UKCRC code/ Disease: Metabolic and Endocrine/ Diabetes mellitusNutritional, Metabolic, EndocrineSpecialty: Primary care, Primary sub-specialty: Diabetes
- Registration Number
- ISRCTN62452621
- Lead Sponsor
- niversity of Oxford
- Brief Summary
2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30659044 protocol (added 24/02/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/31709697/ results (added 06/10/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 33
1. Participant is willing and able to give informed consent for participation in the study
2. Male or female, aged 18 years or above
3. BMI of =30kg/m2
4. Diagnosed with type 2 diabetes
5. Patients must have undergone diabetic retinopathy screening within the last 12 months
1. History of, or features suspicious of, an eating disorder
2. Pregnant, breastfeeding, currently undergoing fertility treatment, or planning to become pregnant during the course of the study
3. Recent MI or CVA (<3 months)
4. Uncontrolled ischaemic heart disease, critical ischaemia, uncontrolled hypertension, uncontrolled cardiac arrhythmia (eg inadequate rate control in AF, inadequate episode control paroxysmal AF), cardiac conduction abnormality (eg long QT syndrome)
5. Cardiac failure (Grade II New York Heart Association, and more severe)
6. Renal failure (CKD Stage 4 or 5)
7. Active treatment for cancer (other than skin cancer treated with curative intent by local treatment only)
8. Intercurrent serious infection at time of recruitment
9. Diagnosed with a significant psychiatric disorder or substance abuse
10. Serious neurological disorder, including epilepsy
11. Recently undergone significant surgery (<6 months)
12. History of bariatric surgery, including gastric banding
13. Are currently using a fasting”/low-energy diet
14. Unwilling to consider any dietary changes
15. Unable to understand English
16. Are currently using insulin therapy, or SGLT2 inhibitors (Glifozins – e.g. empaglifozin, dapaglifozin, canaglifozin)
17. Non-proliferative retinopathy level R2 or worse (ie, any level more severe than background” non-proliferative diabetic retinopathy, R1), proliferative diabetic retinopathy, or maculopathy
18. HbA1c = 93mmol/mol (10.5%)
19. Recruiting physician feels they are inappropriate for recruitment due to any other reason
NB: If the patient is taking warfarin, they are not excluded from participating in the study, but will be advised to inform their local monitoring service about their participation, and they may be advised to have additional blood test monitoring of their INR as part of their care.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> The feasibility of the behavioural and dietary intervention, delivered in primary care, aiming to promote weight loss and improved glycaemic control, and whether to progress to a full-scale RCT. The measures of feasibility are:<br> 1. The proportion of allocated intervention group participants who attempt the dietary intervention after randomisation, assessed through nurse documentation at intervention visit<br> 2. Fidelity of intervention delivery: the proportion of essential elements included in intervention delivery sessions; evaluation of transcribed audio-recordings following intervention delivery visits, assessed against a checklist of essential elements<br> 3. The proportion of enrolled participants who attend the final follow-up session, assessed at 12 weeks<br>
- Secondary Outcome Measures
Name Time Method