Abstract
Introduction
Despite advances in diabetes care, cardiovascular disease (CVD) remains the leading cause of morbidity and mortality in type 2 diabetes mellitus (T2DM), with significant residual risk despite optimal glycaemic control. Targeting upstream vascular mechanisms beyond metabolic endpoints is therefore essential through more holistic and integrative approaches to effectively prevent cardiovascular complications in T2DM. Endothelial dysfunction plays a central role in accelerating atherosclerosis and premature vascular ageing in T2DM, thereby increasing the cardiovascular risk, making it a key therapeutic target. This study aims to rigorously evaluate the effect of a structured yoga-based lifestyle programme on endothelial function, markers of vascular ageing and quality of life in individuals with T2DM and to elucidate potential mechanisms of action through assessment of autonomic, inflammatory, oxidative and metabolic pathways.
Method and analysis
A prospective, four-arm, parallel-group, randomised, open-label, blinded end-point study will be conducted at a tertiary care hospital on a total of 248 (62 per arm) adults aged between 30 and 70 years and have a confirmed diagnosis of T2DM for at least 1 year. Three yoga-based intervention groups will receive different components of yoga-based lifestyle intervention in addition to standard medical care, and the control group will receive standard medical care alone. The yoga intervention will be delivered over 12 weeks, comprising supervised sessions twice weekly, supplemented by guided home practice. The primary outcome is the change in endothelial function assessed by flow-mediated dilatation. Secondary outcomes include arterial stiffness, vascular ageing markers, glycaemic and lipid profiles, autonomic function, oxidative stress, quality of life and cost of care. Outcome assessments will be performed at baseline, 3, 6 and 12 months, with outcome assessors blinded to group allocation. Data will be analysed according to the intention-to-treat principle. Analysis of covariance and mixed-effects models will assess intervention effects, with sensitivity analyses. Effect estimates and their 95% CIs will be reported.
Ethics and dissemination
The study has received approval from the Institutional Ethics Committee of SDM College of Medical Sciences and Hospital, India (approval no. SDMIEC/2025/1075). The study findings will be disseminated through peer-reviewed scientific publications, presentations at national and international conferences and stakeholder meetings, with the aim of informing integrative strategies for effectively preventing cardiovascular complications in T2DM.
Trial registration number
CTRI/2024/10/075712.