Topic: Diabetes Research Network, Primary Care Research Network for England
Conditions
Interventions
The study involves an 8-week period of very low calorie diet (800 cal per day) using liquid based-formula diet (Optifast®) to induce weight loss. In addition to the three sachets of Optifast® per day,
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For type 2 diabetes volunteers: 1. Duration of diabetes up to 2 years 2. Aged between 25 - 65 years, either sex 3. Body mass index (BMI) of 30 - 40 kg/m^2 with stable body weight for preceeding 3 months 4. HbA1c between 6.2 and 9.0% 5. On treatment with diet alone or diet plus metformin For healthy controls: 1. Normal glucose tolerance plasma fasting triglyceride less than 1.8 mmol/l 2. No family history of type 2 diabetes 3. Matching BMI and age
Exclusion criteria
Exclusion criteria: 1. Kidney dysfunction (serum creatinine greater than 150 micromol/l) 2. Liver dysfunction (serum alanine aminotransferase [ALT] greater than 2.5 upper limit normal) 3. Contraindications to magnetic resonance imaging (MRI) (metal implants and claustrophobia) 4. Consumption of greater than 14 units of alcohol per week 5. Treatment with sulphonylureas, thiazolidinediones, steroids or beta-blockers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Liver fat content 2. Pancreatic fat content 3. Hepatic insulin sensitivity 4. Glucose-induced insulin secretion Each of the above is measured at baseline, week 1, week 4 and week 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| Glucose control | — |
Countries
United Kingdom
Outcome results
None listed