DIAMOND
Research type
Research Study
Full title
Dietary Approaches to the Management Of type 2 Diabetes (DIAMOND) cluster randomised trial
IRAS ID
307150
Contact name
Paul Aveyard
Contact email
ISRCTN Number
ISRCTN46961767
Duration of Study in the UK
23 years, 2 months, 30 days
Research summary
Aim
To show whether a low energy low carbohydrate food-based diet and support from practice nurses can help people with recently diagnosed type 2 diabetes achieve remission, meaning no need for diabetes medicines.Background
The DiRECT trial showed that nearly half of people with type 2 diabetes diagnosed in the last six years had remission of diabetes following an intensive weight loss programme in which participants stopped eating their normal food and ate specially formulated “total diet replacements”. However, total diet replacements do not appeal to all.
We developed the DIAMOND programme using “real food”, with realistic support provided in the NHS. We tested this in a “feasibility trial”, which showed we could recruit people who followed the programme with nurses delivering the programme as intended. Participants lost 10kg and two thirds had blood glucose in the non-diabetic range at three months. We will show whether this can be maintained.Design & methods
We aim to recruit 506 people who are socially representative of the UK population. We will ask practices to write to people with diabetes who are overweight and meet the study criteria. Interested persons will telephone the trial team for more details. If the person appears eligible, s/he will see a nurse at the local practice who will confirm consent and measure height, weight, blood pressure, and a blood test for blood glucose control and cholesterol.
We will decide at random if practices will provide usual care for diabetes or offer the DIAMOND programme. Participants in practices offering the programme will be invited to see the nurse seven times over 6 months. Some will be invited to take part in an interview.
At 1 year, we will repeat the baseline measures. The main outcome is whether people have achieved remission. Thereafter, we will assess whether people have diabetes through the National Diabetes Audit.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
22/EM/0074
Date of REC Opinion
4 Apr 2022
REC opinion
Further Information Favourable Opinion