Investigating the limits of reversibility of type 2 diabetes

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2012
INTERVENTION: Restated interventions as of 31/07/2015: Dietary modification, Very low calorie diet; Physical activity, Increased physical activity levels. The weight maintenance interventions are of 6 months duration and primarily involve a level of calorie intake to maintain weight steady. The randomised sub‐study tests involve either a high monounsaturated fat diet or usual diet, and increased physical activity or usual physical activity. Previous interventions: Dietary modification, Very low calorie diet; Physical activity, Increased physical activity levels. The weight maintenance interventions are of 6 months duration and involve either a high monounsaturated fat diet or usual diet, and increased physical activity or usual physical activity. CONDITION: Diabetic Control, Nutrition, Obesity ; Nutritional, Metabolic, Endocrine ; Non‐insulin‐dependent diabetes mellitus PRIMARY OUTCOME: Restated primary outcome measures as of 31/07/2015:; Fasting plasma glucose at 6 months in the group achieving non‐diabetic levels at 10 weeks (following VLCD and return to normal eating); ; Previous primary outcome measures:; Beta cell function measured at baseline, 8 weeks and 8 months SECONDARY OUTCOME: Added 31/07/2015:; Change in beta cell function from 10 weeks to 6 months INCLUSION CRITERIA: 1. Type 2 diabetes of < 4 years or > 8 years duration 2. HbA1c < 80 mmol/l / 9.5% 3. BMI 28‐40kg/m2 4. Age 25‐80 years 5. Stable weight for previous 6 months (within 5kg) 6. Male and female participants
Epistemonikos ID: 051e7375743bcc35e4bd9481ac8b75826b249d2a
First added on: Aug 22, 2024