Effect of Metformin on Disease Progression in Patients With Cryptogenic Cirrhosis (NASH-related Cirrhosis) With Diabetes or Impaired Glucose Tolerance or Insulin Resistance: a Prospective Randomized, Open Labeled, Clinical Trial"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Reduction of portal pressure
研究概览
简要总结
In this study, consecutive patients with cryptogenic cirrhosis (NASH-related cirrhosis), coming to ILBS (Institute of Liver & Biliary Sciences) OPD (Out patient Department) or getting admitted in the ward will be enrolled on fulfillment of inclusion/exclusion criteria and consent of the patient. These patients will be randomised to either metformin arm or conventional treatment arm. After enrollment these subjects will be monitored every three monthly for total of 12 months or till the primary endpoint is achieved. At the end of the study, outcome will be measured appropriately.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and above
- •Patients with cryptogenic cirrhosis {NASH (Nash Alcoholic Steatohepatitis)-related cirrhosis}
- •Presence of diabetes mellitus or insulin resistance
排除标准
- •Patients with heart failure
- •Patients with acute kidney injury at the time of enrollment
- •Patients with CKD (Chronic Kidney Disease) or with S. Creatinine > 1 mg/dL
- •Patient with active upper GI bleeding- not settled
- •Patient with SIRS/sepsis/shock
- •Patient in ICU (Intensive Care Unit)
- •Patients with hepatocellular carcinoma
- •Patients who are not willing to participate in the study
- •Patients with any form of decompensation at the time of enrollment in the study
- •Patient with large esophageal varices/ patients who are on beta blocker other than those patients with HVPG (Hepatic Venous Pressure Gradient) non responder to betablocker
- •Patient who has already been receiving Metformin prior to enrollment in the study
研究组 & 干预措施
Metformin
Metformin- 500 mg once daily as a starting dose, can be escalated to 2 g/day to control diabetes
干预措施: Metformin (Drug)
Insulin
干预措施: Insulin (Drug)
结局指标
主要结局
Reduction of portal pressure
时间窗: 1 Year
次要结局
- Improvement in fibrosis(assessed by noninvasive methods like Fibroscan and Fib 4 index)(1 Year)
- Safety profile of the drugs like Random Blood Sugar (RBS) and serum lactate monitoring regularly.(1.5 year)