Type 2 diabetes Nutritional, Metabolic, Endocrine Non-insulin dependent diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: This a multicentre trial recruiting 750 participants from across the South West of England. Individuals must satisfy the following criteria before they can be considered eligible: 1. Type 2 diabetes mellitus (T2DM) as defined by: body mass index (BMI) >25, no ketosis, no significant weight loss prior to diagnosis, aged above 30 at diagnosis 2. Between 5 and 8 months from clinical diagnosis of T2DM
Exclusion criteria
Exclusion criteria: 1. Age over 80 at diagnosis 2. HbA1c of greater than 10% 3. Blood pressure greater than 180/100 4. Low-density lipoprotein (LDL) greater than 4 5. Patients already receiving a maximum dose of a sulphonylurea 6. Have a current diagnosis of unstable angina 7. Have had a myocardial infarction within the previous three months 8. Unable to increase their physical activity 9. Subject is pregnant or is of childbearing age and not surgically sterile, 2 years postmenopausal or does not practice one method of contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycaemic control as measured by HbA1c and systolic and diastolic blood pressure, at 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Lipids, insulin resistance, weight/body composition, and amount of medication required to control diabetes and blood pressure at 12 months. | — |
Countries
England, United Kingdom