Effect of yoga-based lifestyle intervention on endothelial function and vascular ageing in adults with type 2 diabetes: a study protocol for a randomised controlled (Yoga V-AgE) trial.

Cardiovascular disease remains the leading cause of morbidity and mortality in type 2 diabetes mellitus despite advances in diabetes care, with significant residual risk persisting even with optimal glycaemic control.

• The authors identify this residual cardiovascular risk as justification for targeting 'upstream vascular mechanisms beyond metabolic endpoints'
• The paper frames this as motivation for 'more holistic and integrative approaches to effectively prevent cardiovascular complications in T2DM'
• Endothelial dysfunction is identified as playing 'a central role in accelerating atherosclerosis and premature vascular ageing in T2DM'

The trial is designed as a prospective, four-arm, parallel-group, randomised, open-label, blinded end-point study enrolling a total of 248 adults with type 2 diabetes.

• Total sample size is 248 participants, with 62 per arm across four groups
• Participants will be adults aged between 30 and 70 years with a confirmed diagnosis of T2DM for at least 1 year
• The study will be conducted at a tertiary care hospital
• Three groups will receive different components of yoga-based lifestyle intervention in addition to standard medical care; the control group receives standard medical care alone
• Outcome assessors will be blinded to group allocation

The yoga intervention is structured to be delivered over 12 weeks with supervised sessions twice weekly supplemented by guided home practice.

• The intervention duration is 12 weeks
• Supervised sessions are conducted twice weekly
• Home practice is guided and supplementary to supervised sessions
• Three distinct yoga-based intervention arms will receive different components of the yoga-based lifestyle intervention, allowing for component-level analysis

The primary outcome of the trial is the change in endothelial function assessed by flow-mediated dilatation (FMD).

• Flow-mediated dilatation is the designated primary outcome measure
• Outcome assessments will be performed at baseline, 3, 6, and 12 months
• The longitudinal follow-up extends to 12 months, beyond the 12-week active intervention period

Secondary outcomes span multiple physiological and patient-reported domains including arterial stiffness, vascular ageing markers, glycaemic and lipid profiles, autonomic function, oxidative stress, quality of life, and cost of care.

• The secondary outcomes include arterial stiffness and vascular ageing markers as distinct endpoints
• Mechanistic pathways to be assessed include autonomic, inflammatory, oxidative, and metabolic pathways
• Cost of care is included as a secondary outcome, enabling health economic analysis
• Quality of life is included as a patient-reported secondary outcome

Data will be analysed according to the intention-to-treat principle using analysis of covariance and mixed-effects models, with effect estimates reported as 95% confidence intervals.

• Primary analytical approach is intention-to-treat
• Analytical methods include analysis of covariance (ANCOVA) and mixed-effects models to assess intervention effects over time
• Sensitivity analyses are planned
• Effect estimates and their 95% CIs will be reported

The study received ethics approval from the Institutional Ethics Committee of SDM College of Medical Sciences and Hospital, India, and is registered in the Clinical Trials Registry of India.

• Ethics approval number: SDMIEC/2025/1075
• Clinical trial registration number: CTRI/2024/10/075712
• Dissemination plans include peer-reviewed publications, national and international conference presentations, and stakeholder meetings