Nutritional, Metabolic, Endocrine: Diabetes Nutritional, Metabolic, Endocrine Diabetes
Conditions
Interventions
Current interventions as of 07/05/2013:
Arm 1: Control Intervention (n=100)
will be given standard healthy lifestyle advice.
Arm 2: Behavioural Lifestyle Intervention based on a self-efficacy model (n=100)
encompassing individual and group advice on diet, exercise and smoking cessation over six fortnightly sessions.
Metformin 500 mg twice daily (bd) will be offered to all participants at 6 months.
Pre
will be given standard healthy lifestyle advice.
Arm 2: Behavioural Lifestyle Intervention based on a self-efficacy model (n=50)
encompassiing individual and group advice on diet, exercise and smoking cessation over six fortnightly sessions.
Arm 3: Pharmacotherapy only (n=50)
Metformin 500 mg twice daily (bd) will be given to participants as well as standard healthy lifestyle advice.
Arm 4: Both behavioural and pharmacotherapy (n=50).
Interventions provided at time of r
Sponsors
Queen Mary, University of London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 07/05/2013: For screening strategies, 500 people of Bangladeshi origin aged 20-70 years divided into two groups: 1. Dataset 1 will be invited to have an Oral Glucose Tolerance Test (OGTT) and fasting lipid profile and then if at high risk of diabetes invited to intervention 2. Dataset 2 will be identified as high risk from GP records and then invited directly for intervention Previous inclusion criteria: 500 subjects of Bangladeshi origin aged 20-65 years divided randomly into two groups, dataset 1 being invited to have an Oral Glucose Tolerance Test (OGTT) and fasting lipid profile.
Exclusion criteria
Exclusion criteria: Added as of 07/08/2007: 1. Outside age range 2. Major co-morbidity including cardiovascular disease, diabetes and cancer 3. Contra-indications to metformin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure as of 07/08/2007: In non-diabetic Bangladeshi participants to test the feasibility of key aspects of identification, recruitment methods, the screening process, interventions and measurement of outcomes for a culturally appropriate RCT to prevent diabetes and subsequent cardiovascular disease. Previous primary outcome measures: Cambridge risk score and Finnish score | — |
Secondary
| Measure | Time frame |
|---|---|
| Added as of 07/05/2013: 1. Ascertaining the quality of the datasets that can be used to determine risk held in primary care databases and what actions are required to ensure that they are complete 2. Designing, validating and establishing cut-off points for a disease susceptibility risk score to assess whether it is feasible to identify people with the metabolic syndrome in the Bangladeshi community 3. Proportion of eligible people consenting to randomisation (phase 3) and the adherence to or concordance with the intervention by those identified as having metabolic syndrome by direct testing (phase 1) compared to those identified as high risk from the CRS (phase 2) 4. From phase 1 the prevalence of metabolic syndrome, IGT and diabetes in the study population 5. Does venesection impair recruitment? 6. Training manual for lay tutors and a set of SOPs for a future trial 7. Adherence, acceptability and attendance of the behavioural lifestyle intervention 8. Adherence with the study drug in an otherwise ?well? population 9. An approximate indication of changes and variability of possible outcome variables (fasting glucose, waist, weight, BP and conversion to diabetes) in the intervention group as a whole rather than by treatment group. 10. Development and translation of culturally appropriate questionnaires (GHQ12, SF12, modified diabetes IPQ-R and RPAQ) and the feasibility of their use individually and combined in the Bangladeshi community 11. The design of a culturally appropriate RCT of a multi-factorial intervention to prevent diabetes and subsequently cardiovascular disease in the local Bangladeshi community 12. Cost-effectiveness model informing cost data collection in the main trial 13. Judgement about the viability of the main trial with Bangladeshi participants from Tower Hamlets | — |
Countries
United Kingdom
Outcome results
None listed