Type 2 diabetes Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men and women aged 20-65 years, all ethnicities 2. T2DM of duration 0-6 years 3. Body Mass Index (BMI) >27 kg/m2
Exclusion criteria
Exclusion criteria: 1. Current insulin use 2. HbA1c =12% 3. Substance abuse 4. Known cancer 5. Myocardial infarction within previous 6 months 6. Learning difficulties 7. Current treatment with anti-obesity drugs 8. Diagnosed eating disorder or purging 9. Pregnant/considering pregnancy 10. Patients who have required hospitalisation for depression or are on antipsychotic drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in weight of 15 kg (assumed equal on average to 15%) or more Co-primary outcome: Reversal of diabetes (HbA1c <6.5%) Both outcomes measured at 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life measured by EQ-5D questionnaire 2. Physical activity level measured using Sensewear Monitor 3. Serum lipids All outcomes measured at 1 year | — |
Countries
Scotland, United Kingdom