Efficacy of Yoga in patients with Metabolic dysfunction associated Steatotic Liver Disease - An open label, Non- Inferiority, Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Effectiveness of yoga in improving the hepatic steatosis in patients with MASLD in comparison to standard of care
研究概览
简要总结
Body weight reduction by lifestyle interventions including physical exercise and dietary calorie restriction is the mainstay for the management of MASLD. Recently there has been much interest about Yoga as a lifestyle intervention in controlling bodyweight and improving liver steatosis. However the evidence is limited. The study is open - label, Non inferiority, randomised controlled trial to compare the efficacy of Yoga with dietary calorie restriction versus Exercise with dietary calorie restriction at the end of 6 months in 100 patients with MASLD. The study will be conducted at single institute - PGIMER, Chandigarh. The primary outcome will be to compare improvement in hepatic steatosis in patients doing Yoga to those doing exercise. As secondary outcome, the amount of body weight reduced, reduction in BMI, improvement in central obesity, improvement in lipid profile, insulin resistance and improvement in sarcopenia and frailty will be compared in both the groups.
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with MASLD: defined by the presence of hepatic steatosis on ultrasound or using CAP parameters (of Fibroscan) together with the presence of at least one of five cardiometabolic criteria after ruling other causes of hepatic steatosis.
- •Overweight and obese patients as per Asia-Pacific criteria (BMI ≥ 23 and ≥ 25Kg/m2) respectively.
- •All patients must be on stable doses of medical therapy for hypertension or diabetes for atleast 6 weeks before the study start date.
- •Be willing and able to participate in the full program.
- •Be willing and able to functionally participate in all activities set as part of the intervention.
- •Be able to complete all day-to-day activities and instrumental activities of daily living independently, completely without assistance from others.
- •Consent to participate in study.
排除标准
- •Patients who are not willing to give consent for the study.
- •Patients who will not be able to carry out yoga and exercise protocol safely, recent fall or > 3 falls in a year, recent hospitalization in 1 month, and those who fail to give consent will be excluded.
- •The patients with severe cardio-pulmonary disease, coronary artery disease, cardiomyopathy, severe musculoskeletal disease, neuropsychiatric disease, history of cardiovascular accident, active malignancy, hepatocellular carcinoma and, the end-stage renal disease.
- •Patients with decompensated cirrhosis or post liver transplant patients 5)Pregnant, lactating women 6)Patients having prior study enrolment or enrolment in another conflicting study within past 3 months.
- •Patients taking weight loss drugs or oral antidiabetic medications (GLP-1 analogues and glitazones) or any pharmacotherapy for NASH (Vitamin E and Saroglitazar).
结局指标
主要结局
Effectiveness of yoga in improving the hepatic steatosis in patients with MASLD in comparison to standard of care
时间窗: 6 months
次要结局
- Effectiveness of yoga in decreasing the body weight, BMI, central obesity in patients with MASLD in comparison to standard of care.(6 months)
- Effectiveness of yoga in improving liver variables (inflammation, fibrosis) and metabolic variables (dyslipidemia, hyperglycemia, insulin resistance) in patients with MASLD in comparison to standard of care.(6 months)
- Effectiveness of yoga in improving the sarcopenic obesity and frailty in patients with MASLD in comparison to standard of care.(6 months)
研究者
Dr Sunil Taneja
Postgraduate Institute of Medical Education and Research