Diabetes Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged 40-69 with a diabetes risk score more than or equal to 0.17 (representing the top 25% of risk distribution) are invited for a random capillary screening test for diabetes. Patients are eligible to take part if the diagnosis of diabetes is confirmed by subsequent fasting capillary test and oral glucose tolerance test. Following the funded extension, inclusion criteria extended to include patients aged 40 to 69 years with type 2 diabetes diagnosed within the last 3 years.
Exclusion criteria
Exclusion criteria: Potential participants are excluded if they are pregnant or lactating, have a psychotic illness or have an illness with a likely prognosis of less than 1 year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The principal comparisons between I1 and I2 include changes in weight, self-reported physical activity (IPAQ, EPAQ2), diet (Food Frequency Questionnaire), medication adherence (MARS), smoking status and differences at 1 year in objectively measured physical activity (PAR, CSA [accelerometer]), diet (plasma vitamin C) and medication adherence (plasma drug levels). A cross domain measure of behaviour change at 1 year is under development. Modelled 5-year risk of cardiovascular events, incorporating glycaemia, blood pressure and lipid levels, represents the main outcome for the trial of intensive treatment (RC vs I). In addition, we propose to assess at all levels along our causal pathway psychological measures (illness perceptions, attitudes and intentions towards targeted healthy behaviours), anthropometric variables (weight, body fat distribution and waist circumference) and biochemical parameters (HbA1c, cholesterol and albumin/creatinine ratio). | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
United Kingdom