Project duration: 5 years
Geographical domain of the project: The entire country
Study Design: Multi-center, randomized, double-blind, parallel group, pragmatic, primary prevention trial
Cardiovascular Diseases (CVDs) are the leading cause of death among non-communicable diseases. Type 2 diabetes is one of the greatest risk factors of CVDs as CVDs accounts for about 60% of all deaths in diabetic people. In Iran, the prevalence of CVDs in diabetic people is 7% in both sexes, while it is 1.4 % in total population. As pre diabetes is a proceeding state to type 2 diabetes in 25% of cases in a three to five years period, the reduction of cardiovascular risk among those with pre diabetes /type 2 diabetes is of critical importance.
Metformin is an established drug which is widely used in Iran and is available in a low price but the benefits of its usage for delay in or prevention of diabetes is controversial. So this study aims to overcome these gaps and assess the efficacy of Metformin in pre-diabetics focusing on converging to diabetes and reducing cardiovascular diseases related risk and events.
The results of this study can help the policy makers to plan for integrating the feasibility of prescribing this medicine in primary health care (PHC) as a low cost and accessible strategy to reduce major common non-communicable diseases in disadvantages areas.
Samples under study
The first phase with sample of 1500 individuals will commence in 2017. The second phase will be expanded to approximately 13,500 Iranian participants through national diabetes research network in Iran.
Evaluating the efficacy of adding metformin to the usual care of participants with cardiovascular diseases in at risk non-diabetic hyperglycemia individuals, including:
- Diabetes incidence decreasing
- Reduce cardiovascular diseases incidence in high risk pre diabetics