Dietary Approaches to the Management Of type 2 Diabetes (DIAMOND) cluster randomised trial

niversity of Oxford0 个研究点目标入组 626 人开始时间: 2022年4月7日最近更新: 2024年1月15日

适应症

试验速览

2023 Protocol article in https://doi.org/10.1016/j.cct.2023.107199 (added 25/04/2023)

•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

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