Cardiovascular disease remains the leading cause of morbidity and mortality among people with type 2 diabetes (T2DM) despite improvements in glycaemic management. The protocol frames the unmet need as residual cardiovascular risk that persists beyond conventional metabolic endpoints, arguing for upstream vascular targets and more integrative, holistic approaches.
Central to the trial rationale is the role of endothelial dysfunction in accelerating atherosclerosis and premature vascular ageing in T2DM, which elevates cardiovascular risk. The study therefore targets endothelial function and related markers of vascular ageing as primary therapeutic end points and seeks to test whether a structured yoga-based lifestyle programme can modify these vascular mechanisms while also improving clinical and patient-reported outcomes.
Yoga V-AgE is described as a prospective, four-arm, parallel-group, randomised, open-label study with blinded end-point assessment. The trial will be conducted at a tertiary care hospital and will enrol a total of 248 participants, allocated equally to four groups (62 per arm). Outcome assessors will be blinded to group allocation to minimise assessment bias.
Eligible participants are adults aged 30 to 70 years with a confirmed diagnosis of T2DM for at least one year. The source text does not provide further inclusion or exclusion criteria, recruitment targets by source population, or screening procedures; those details were not reported in the source and are not inferred here.
The trial includes three distinct yoga-based intervention groups plus a control group. The three intervention arms each receive different components of the structured yoga-based lifestyle intervention in addition to standard medical care. The control group receives standard medical care alone.
The yoga intervention is delivered over 12 weeks and comprises supervised sessions twice weekly, supplemented by guided home practice. Precise content of the different yoga components, instructor qualifications, session duration, adherence strategies, and home practice materials were not detailed in the source and therefore are not described here.
The primary outcome is change in endothelial function measured by flow-mediated dilatation (FMD). Secondary outcomes include measures of arterial stiffness, markers of vascular ageing, glycaemic and lipid profiles, autonomic function, indices of oxidative stress, quality of life, and cost of care.
Outcome assessments are scheduled at baseline, 3 months, 6 months and 12 months. Outcome assessors are blinded to group allocation to reduce detection bias. The source does not specify the exact instruments or laboratory assays for each secondary outcome, so those methodological specifics are not reported here.
All analyses will follow the intention-to-treat principle. Intervention effects will be assessed using analysis of covariance (ANCOVA) and mixed-effects models to account for repeated measures and potential clustering over time. Effect estimates will be presented with 95% confidence intervals. Sensitivity analyses are planned to test robustness of findings. The source does not provide further details on sample size calculations, statistical power assumptions, handling of missing data methods, or multiplicity adjustments; these were not reported in the source.
Beyond clinical end points, the trial intends to elucidate potential mechanisms of action by assessing autonomic function, inflammatory pathways, oxidative stress, and metabolic parameters. These mechanistic assessments are designed to link a yoga-based lifestyle approach with changes in vascular function and ageing markers in adults with T2DM. Specific biomarkers, assays, or autonomic testing protocols were not detailed in the source document.
The study received ethics approval from the Institutional Ethics Committee of SDM College of Medical Sciences and Hospital, India (approval no. SDMIEC/2025/1075). The trial is registered under CTRI/2024/10/075712. Planned dissemination includes publication in peer-reviewed journals, presentations at national and international conferences and stakeholder meetings, with the explicit aim of informing integrative strategies to prevent cardiovascular complications in people with type 2 diabetes.