Comparative assessment of yoga-based intervention vs. American Diabetes Association exercise regime along with standard of care for autonomic Neuropathy in diabetes mellitus: An Exploratory clinical trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- effect of Yoga based intervention on Autonomic function in Type Two Diabetes Mellitus patients suffering from Autonomic Neuropathy
研究概览
简要总结
Yoga may also reduce activation of the sympathoadrenal system and hypothalamic-pituitary-adrenal axis, and may enhance parasympathetic activity, thereby alleviating stress. Clinical trials with both healthy and ill participants have shown the benefit of yoga on stress reduction. By supporting stress resilience, yoga may prevent stress-induced rises in cortisol, thus controlling the rise in blood glucose levels. Pilot studies conducted mainly in India have shown decreased stress levels among diabetics after a yoga intervention. Evidence also suggests that stress leads to poor food choices, including increased consumption of foods high in fat, sugar, and salt. By reducing stress and improving mindfulness, yoga practice may lead to improved self-care behaviors including improved diet and physical activity. Randomized trials with adults at risk for cardiovascular disease and binge eaters have shown improved dietary outcomes after a yoga intervention. Thus, yoga may positively impact stress, diet, and other self-care tasks that contribute to improved glycaemic control.
Aim:
To compare the efficacy of yoga-based intervention vs. American Diabetes association exercise regime in addition with standard of care for autonomic neuropathy in type two diabetes mellitus
Hypothesis
Yogic exercises are equally effective as compared to the American Diabetes association exercise regime for improving autonomic functions in patients suffering from diabetic autonomic neuropathy
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 35.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of Type two diabetes mellitus with diagnosed Autonomic Neuropathy. Age Between 35.
排除标准
- •ïƒ˜Patients opting for treatment not in compliance with randomization sequence Patients on insulin Patients with HbA1c > 11%.
- •ïƒ˜Patients with acute macro vascular complications, cancer, pulmonary tuberculosis, and rheumatoid arthritis Patients who will be unable to perform yoga.
- •ïƒ˜Patients receiving drugs like drotaverine, beta-blockers or any other drug likely to affect autonomic function tests Patients with history of angina/uncontrolled hyperglycaemia/any other contraindication applied by American Diabetic Association (ADA).
结局指标
主要结局
effect of Yoga based intervention on Autonomic function in Type Two Diabetes Mellitus patients suffering from Autonomic Neuropathy
时间窗: baseline , 4 week, 8th week and 12th week
次要结局
- Change in HbA1c, lipid profile, Nerve Conduction Velocity, Liver function test, Kidney function test, fasting blood sugar, Post prandial blood sugar, Random blood Sugar(Change in HbA1c, lipid profile, Nerve Conduction Velocity, Liver function test, Kidney function test, fasting blood sugar, Post prandial blood sugar, Random blood Sugar)
- Change in dose of Oral hypoglycaemic agents(4th week, 8th week and 12 week)