Type 2 diabetes Nutritional, Metabolic, Endocrine
Conditions
Interventions
The researchers will test in a randomised controlled trial the effectiveness of a low-carbohydrate, low-energy diet with remote support for patients with type 2 diabetes.
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the study 2. Male or Female, aged 18 – 65 years old 3. BMI equal to or over 27kg/m² (where individuals are from White ethnic groups) or equal to or over 25kg/m2 (where individuals are from Black, Asian and other ethnic groups) 4. Diagnosed with type 2 diabetes 5. Must have good IT skills (they can use a computer/smartphone) 6. Must complete baseline assessments
Exclusion criteria
Exclusion criteria: 1. Currently diagnosed with type 2 diabetes but who are in remission using the NHS diabetes remission criteria, or who are recorded as not on diabetes medication and whose HbA1c levels on enrolment are <48mmol/mol at baseline 2. Currently using insulin injections 3. GLP1-agonists or SGLT2 inhibitors started in the six months before study enrolment 4. Diagnosed with a known eating disorder for whom the programme could be unsafe or require extensive monitoring to ensure safety 5. People who are pregnant or planning pregnancy 6. People who are breastfeeding 7. Diagnosed with a myocardial infarction or stroke in the past three months, or uncontrolled cardiac conduction abnormalities e.g. long QT syndrome. 8. Currently diagnosed with maculopathy or proliferative retinopathy 9. People with HbA1c =87mmol/mol 10. People with significant life-limiting illnesses that mean that remission is unlikely to improve health (severe cardiac failure, palliatively treated cancer, dementia), or other current severe illness 11. 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 eDIAMOND or the other research study/ies that they are participating in. 13. Taking part in or planning to take part in the NHS Pathway to Remission programme.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in weight measured by weighing participants at the 20-week follow-up appointment and comparing this to the measurement taken at baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in HbA1c measured using a blood sample taken at the 20-week timepoint 2. Number of participants with HbA1c <48mmol/L on no medications measured using a blood sample taken at the 20-week timepoint 3. Change in diabetic medication (number of diabetic medications; change in anti-glycaemic medication effect score) measured using medical notes at the 20-week timepoint 4. Change in total cholesterol, LDL-cholesterol, total cholesterol:HDL ratio, triglycerides measured using a blood sample taken at the 20-week timepoint 5. Change in BP (systolic, diastolic) measured using a blood pressure monitor reading at the 20-week timepoint 6. Change in antihypertensive medication (number of medications measured using medical notes at the 20-week timepoint 7. Change in patient’s well-being measured using the WHO-5 Well-Being Index (WHO-5) and the Problem Areas in Diabetes (PAID) scale score at the 20-week timepoint 8. Percentage of people who fulfil the recruitment criteria who accept the invitation to participate measured using study records at the baseline timepoint 9. Participant adherence to the protocol assessed by self-reported carbohydrate intake measured using an online food intake questionnaire at the 20-week timepoint 10. To see whether the control group may have also changed their carbohydrate intake (contamination), assessed by self-reported carbohydrate intake measured using an online food intake questionnaire at the 20-week timepoint 11. To explore the experience of the intervention for participants and the impact of the programme on participants’ lives and behaviour measured using telephone interviews with participants and an online questionnaire at the 20-week timepoint | — |
Countries
England, United Kingdom
Contacts
Public ContactDaisy Harrison
Outcome results
None listed