Type 2 diabetes Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Body mass index (BMI) range 27 - 40 kg/m2 2. HbA1c greater than 7% but less than 11% (Diabetes Control and Complications Trial [DCCT]) at screening 3. Previously treated with diet alone or oral monotherapy (i.e., metformin or sulphonylurea). Subjects on monotherapy had discontinued medication during the six-week run-in period. 4. Males, aged between 50 - 70 years
Exclusion criteria
Exclusion criteria: 1. Subjects on warfarin treatment 2. Subjects treated with insulin currently or in the previous 12 months 3. Previous intolerance of metformin or sulphonylurea 4. Presence of contra-indication to metformin therapy for example renal disease or congestive cardiac failure 5. Cardiovascular event (i.e., electrocardiogram (ECG)/troponin proven myocardial infarction [MI] or cerebrovascular accident [CVA]) in previous 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured at the end of each 10-week study phase: 1. Body mass index 2. Blood pressure 3. Analysis of routine blood samples (fasting venous blood samples for urea, creatinine, electrolytes, total cholesterol, triglycerides, high density lipoprotein [HDL]-cholesterol, loew density lipoprotein [LDL]-cholesterol, glucose, liver function tests and HbA1C) 4. Analysis of non-routine blood samples (total adiponectin, tumour necrotising factor-alpha [TNF-a], interleukin-6 [IL-6] and asymmetric dimethyl-arginine [ADMA]) 5. Pulse wave velocity (PWV) 6. Wire myography 7. Adipose AMPK activity assays | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
United Kingdom