Impact of Yoga on Atherosclerotic Cardiovascular Disease Risk Reduction in Type-2 Diabetes (Yoga-AtheroCaRRe):Exploring the Protective Effects and Molecular Mechanisms
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in 10-year ASCVD risk score from baseline at 12 weeks and 24 weeks following the structured yoga lifestyle intervention in individuals with T2DM
研究概览
简要总结
Type 2 diabetes mellitus (T2DM) is associated with a markedly increased risk of atherosclerotic cardiovascular disease (ASCVD), which remains the leading cause of morbidity and mortality in this population. Despite standard pharmacological management, a substantial residual cardiovascular risk persists, highlighting the need for complementary lifestyle-based interventions. Yoga, a traditional mind–body practice, has shown benefits in improving glycemic control, lipid profile, stress, and autonomic balance; however, its impact on composite ASCVD risk and underlying molecular mechanisms in individuals with T2DM has not been adequately studied.
The Yoga-AtheroCaRRe study is a prospective, randomized, open-label, blinded end-point (PROBE) trial designed to evaluate the efficacy of a structured yoga lifestyle intervention in reducing 10-year ASCVD risk in individuals with T2DM. A total of 150 participants will be randomized in a 1:1 ratio to receive either a structured yoga lifestyle program along with standard care or enhanced standard care alone. The intervention includes supervised yoga practices, breathing exercises, meditation, and lifestyle modifications.
Primary outcome is the change in 10-year ASCVD risk score at 3 and 6 months using validated risk prediction tools. Secondary outcomes include changes in glycemic status, lipid profile, psychosocial stress, autonomic function, endothelial function, inflammatory and oxidative stress markers, and ASCVD-related gene expression. This study aims to generate evidence on the clinical and molecular benefits of yoga as a sustainable adjunctive strategy for cardiovascular risk reduction in T2DM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Diagnosed with type 2 diabetes mellitus for at least 1 year, based on ADA criteria.
- •Willingness to provide informed consent and comply with trial procedures.
排除标准
- •Systolic blood pressure greater than or equal to 139 mmHg and or diastolic blood pressure greater than 89 mmHg, or currently on antihypertensive medication.
- •History of cardiovascular disease.
- •Presence of neuromuscular disorders or joint pain that would interfere with the ability to perform yoga.
结局指标
主要结局
Change in 10-year ASCVD risk score from baseline at 12 weeks and 24 weeks following the structured yoga lifestyle intervention in individuals with T2DM
时间窗: Change in 10-year ASCVD risk score from baseline at 12 weeks and 24 weeks following the structured yoga lifestyle intervention in individuals with T2DM
次要结局
- Immediate modulation of ASCVD-related gene expression in polymorphonuclear cells assessed after the 7-day yoga lifestyle training program.(baseline & 8th day)
- Changes in glycemic parameters, lipid profile, & autonomic function(baseline, 12 weeks & 24 weeks)
- Identification of molecular pathways (inflammation, oxidative stress, endothelial function) mediating the effect of yoga on ASCVD risk reduction in T2DM.
- Comparative performance of validated ASCVD risk prediction tools in estimating 10-year cardiovascular risk in individuals with T2DM
研究者
Dr Guru Praveen S
SDM college of Medical Sciences and Hospital
