Type 2 diabetes Nutritional, Metabolic, Endocrine
Conditions
Interventions
The researchers will test in a randomised controlled trial whether a programme that supports people to experiment with a sequence of interventions aimed at type 2 diabetes remission is more successful
this is a dietary intervention for people with type 2 diabetes aiming to achieve remission (blood glucose levels returning to normal levels without the use of medication) that uses total dietary repla
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the study 2. Adults (aged 18 to 70 years) with type 2 diabetes diagnosed in the past 1 year 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 for recruitment 6. Participant is willing to be randomised to either treatment option
Exclusion criteria
Exclusion criteria: 1. Currently diagnosed with type 2 diabetes but who are in remission 2. People currently following the Pathway to Remission programme, or who have previously followed this programme 3. Currently using insulin injections 4. GLP1-agonists or SGLT2 inhibitors started in the 3 months prior to study enrolment 5. Currently taking an SGLT2 inhibitor for an indication other than type 2 diabetes 6. Diagnosed with a known eating disorder for whom the programme could be unsafe or require extensive monitoring to ensure safety 7. People who are pregnant or planning pregnancy 8. People who are breastfeeding 9. 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 10. People with HbA1c =87mmol/mol 11. People 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 12. People taking part in other research that would compromise either their participation in NewDAWN or the other research study/ies that they are participating in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission from type 2 diabetes at 12 months; a minimum of 3 months off diabetic medication is required, therefore medication usage and HbA1c levels will be measured at 6 months, 9 months (for participants who have a change in medication at 6 months) and 12 months after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Weight measured using body weight scales available at the GP practice at baseline, 6 months and 12 months 2. Blood glucose levels will be measured using HbA1c levels in the blood at baseline, 6 months and 12 months 3. Dyslipidaemia measured using a ratio of total cholesterol and high-density lipoprotein (HDL) cholesterol at baseline, 6 months and 12 months 4. Cardiometabolic risk measured via QRISK 2 or SMART score (for those with a history of cardiovascular disease) at baseline and 12 months 5. Blood pressure (diastolic and systolic) measured using a sphygmomanometer three times seated, each at least 1 minute apart, at baseline, 6 months and 12 months 6. Quality of life measured using problem areas in diabetes score (PAID) and EQ-5D-5L at baseline, 6 months and 12 months | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed