Diabetic Control, Nutrition, Obesity Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus
Conditions
Interventions
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 rand
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 phy
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Type 2 diabetes of 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
Exclusion criteria
Exclusion criteria: 1. Current treatment with thiazolidinediones, GLP-1 agonists or steroids 2. Renal or hepatic dysfunction 3. Contraindications to MRI 4. Alcohol consumption > 3 units per day for women and > 4 units per day for men 5. Allergy to soybean or eggs 6. Highly restrictive diet
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Added 31/07/2015: Change in beta cell function from 10 weeks to 6 months | — |
Countries
United Kingdom
Outcome results
None listed