A low-carbohydrate, low-energy dietary intervention for patients with type 2 diabetes in primary care
- Conditions
- Type 2 diabetes mellitusNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN46961767
- Lead Sponsor
- niversity of Oxford
- Brief Summary
2023 Protocol article in https://doi.org/10.1016/j.cct.2023.107199 (added 25/04/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 626
1. Participant is willing and able to give informed consent for participation in the study
2. Adults (18 to 70 years (inclusive)) with type 2 diabetes diagnosed in the past six years
3. A BMI of at least 27 kg/m² and who may benefit from achieving remission
4. Able to attend baseline visits, adhere to intervention and follow-up appointments
5. Participant is registered at a GP practice that is open and randomised
1. Currently diagnosed with type 2 diabetes but who are in remission using the NHS diabetes remission criteria
2. Currently using insulin injections
3. GLP1-agonists or SGLT2 inhibitors started in the 3 months prior to study enrolment
4. Diagnosed with a known eating disorder for whom the programme could be unsafe or require extensive monitoring to ensure safety
5. Participants who are pregnant or planning pregnancy
6. Participants who are breast feeding or planning to breast feed
7. Diagnosed with a recent myocardial infarction or stroke in the past three months, uncontrolled cardiac conduction abnormalities e.g. long QT syndrome, maculopathy or proliferative retinopathy
8. Participants with HbA1c >= 87mmol/mol
9. Participants with significant life-limiting illnesses that mean that remission is unlikely to improve health (severe cardiac failure, palliatively treated cancer, dementia), other current severe illness or planned major surgery that means that following a weight loss programme would not be possible
10. People taking part in other research that would compromise either their participation in DIAMOND or the other research study(s) that they are participating in
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Remission, defined as HbA1c <48 mmol/mol for 6 months while off diabetes medication between 6 and 12 months assessed by medication use and measurement of HbA1c concentration at both times
- Secondary Outcome Measures
Name Time Method <br> Measured at baseline and 12 months:<br> 1. Glycaemic control measured using concentration of HbA1c (blood test)<br> 2. Lipid profile measured using total cholesterol/HDL ratio<br> 3. Systolic and diastolic blood pressure (sphygmomanometer)<br> 4. Cardiovascular risk measured using QRISK2/SMART score<br> 5. Quality of life measured using problem areas in diabetes (PAID) and WHO-5 scores<br>