CTRI/2025/09/094365招募中不适用
Effect of Diet and Exercise Intervention on Sarcopenic Obesity in Diabetic Patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Prospective Interventional Study
Ritu Yadav1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年9月25日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Improvement in sarcopenia and weight loss
研究概览
简要总结
Two groups will be made according to the inclusion and exclusion criteria
Group I (Control group) will be treated with a tailored dietary regime (a standard of care)
Group II (Study group) will be treated with a tailored dietary regime AND a tailored exercise regime
Interventions will be given for 24 weeks and follow-up will be taken till 52 weeks
The baseline data will be recorded and compared with intervention outcomes so that effect of Diet and Exercise Intervention can be measured in both groups
Data will be analyzed with an appropriate statistical tool.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 19.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Diabetic patients who have sarcopenic obesity with metabolic dysfunction-associated steatotic liver disease (MASLD).
- •can provide written informed consent.
排除标准
- •Compensated and decompensated liver cirrhosis.
- •Large Esophageal Varices.
- •HCC or any other malignancy
- •Poor cardiopulmonary reserve or other advanced systemic disease (other than diabetes mellitus) with expected survival less than 1 year.
- •Patient on the Use of semaglutide T2DM drugs known to induce weight loss (GLP-1 agonists like semaglutide, GLP1-A +GIP-A like Trizepatide)
- •Organ failure.
结局指标
主要结局
Improvement in sarcopenia and weight loss
时间窗: 1 Year
次要结局
- Proportion achieving(1. Improvement in sarcopenia)
研究者
Ritu Yadav
Mahatma Gandhi University of Medical Science & Technology
研究点 (1)
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