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

Does a structured yoga-based lifestyle programme improve endothelial function, vascular ageing markers and quality of life in adults living with type 2 diabetes?

Planned enrolment of 248 adults aged 30–70 with type 2 diabetes of at least one year's duration, tertiary hospital in India (62 per arm)

Protocol for a four-arm, parallel-group, open-label randomised — what this means trial with blinded — what this means outcome assessment: three yoga-based lifestyle intervention variants plus usual medical care vs. usual care — what this means alone, delivered over 12 weeks (twice-weekly supervised sessions plus home practice), with assessments at baseline — what this means, 3, 6 and 12 months

• No results are available — this is a study protocol describing planned methods only.
• Primary endpoint — what this means planned is change in flow-mediated dilatation; secondary endpoints include arterial stiffness, vascular ageing markers, glycaemic and lipid measures, autonomic function, oxidative stress, quality of life and cost of care.
• Planned analysis is intention-to-treat — what this means using ANCOVA and mixed-effects models, reporting effect estimates with 95% CIs.

This trial will eventually test whether adding yoga-based lifestyle work to standard diabetes care affects vascular health outcomes, but no efficacy conclusions can be drawn yet.