The Transform Type 2 Diabetes Study

The aim of this mixed-methods, 12-month interventional study is to understand the effectiveness and acceptability of dietary interventions in type 2 diabetes mellitus (T2DM) in an ethnically diverse population. Three dietary interventions will be offered (total diet replacement, intermittent fasting and a low-carbohydrate diet) and two modes of remote care delivery will be used (group and one-to-one).

Inclusion Criteria:Registered with one of the Nexus Group GP PracticesWilling to give consent for participation including collection of clinical outcomesDiagnosis of type 2 diabetesMinimum age of 18 yearsMaximum age of 70 yearsMinimum BMI of 27kg/m² (adjusted to 25kg/m² in people of South Asian or Chinese origin)Upper weight limit of 180kg (due to upper weight limit of BodyTrace scales)HbA1c eligibility:If on diabetes medication, HbA1c ≥ 43 mmol/molIf on diet alone, HbA1c ≥ 48 mmol/molHbA1c <108mml/molAbility to speak, read and receive care in EnglishAccess to internet and email addressExclusion Criteria:Currently taking insulinPregnant or planning to be pregnant in the next 6 monthsCurrent breastfeedingSignificant physical comorbidities:Active cancer, receiving treatmentMyocardial infarction or stroke in last 6 monthsSevere heart failure defined as equivalent to the New York heart Association grade 3 or 4 (NYHA)eGFR <30 mls/min/1.73m2Active liver disease (except non-alcoholic fatty liver disease (NAFLD),Severe angina, cardiac arrhythmia including atrial fibrillation or prolonged QT syndromeActive substance use disorderActive eating disorderPorphyriaOn current weight management programme / had or awaiting bariatric surgery (unless willing to come off waiting list)Health professional assessment that the person is unable to understand or meet the demands of the programme and/or monitoring requirementsTaking monoamine-oxidase inhibitor medicationTaking warfarinTaking varenicline (smoking cessation medication)Have attended for monitoring and diabetes review when this was last offered, including retinal screening, and commit to continue attending reviews, even if remission is achievedActive/investigation for gastric or duodenal ulcers