The reversal model for metabolic syndrome (RMMS) study: The rationale and design

Background: Recently, attention is paid on strategies and policies to halt or reverse the forecast type 2 diabetes mellitus (T2DM) epidemic across the globe and in India. Metabolic syndrome (MetS) predisposed us to T2DM along with cardiovascular disease (CVD). Our study aims to develop a reversal model for people with MetS through an education program under observation. This paper will describe the design of the reversal model for metabolic syndrome (RMMS) study along with intervention strategies. Materials and Methods: The RMMS study is a multi-center, parallel arm, quasi-experimental study. The study will be done in western (viz., Ahmedabad) and eastern (viz., Guwahati and Dibrugarh) parts compromising 707 patients from each part. The intervention arm will be part of the “observation cum self-management education program” for a period of 6 months. The non-intervention arm will be followed up to 6 months with routine care. The analysis for the outcome will be done at the end of 6 months. The primary outcome measures will be the reversal of MetS or the components of MetS. The piloting of the study has been done after the ethical clearance, and necessary changes are also done in a proforma. Conclusion: The RMMS is first of its kind among Indian population to study the effectiveness of the reversal model. The results will provide insights into changes in the prevalence of the components of MetS and hence can be used as primary prevention strategies for T2DM and CVD.