Study of the Effect of Metformin in Patients With Non-Alcoholic Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- histological and biochemical changes
研究概览
简要总结
The purpose of this study is to examine the effect of metformin on biochemical and histological findings in NAFLD patients with insulin resistance syndrome.
详细描述
Study population:
30 patients will be included who meet all the following criteria: ALT > 2 times normal range; liver histology revealing NASH (type 2-4), without cirrhosis; clinical characteristics of the metabolic syndrome as defined by the NCEP, but no overt diabetes; negative work-up for other causes of liver diseases including alcohol intake < 40 g/week.
All patients will undergo liver biopsy and only patients with type 2-4 (steatosis + inflammation, or steatosis plus ballooning degeneration, or steatosis plus fibrosis and/or Mallory bodies) but without cirrhosis will be included.
Patients who received lipid lowering medications or anti hypertensive drugs prior to study will continue the treatment. Patients who will develop overt type 2 DM with HbAic > 7% during study will be withdrawn.
Intervention:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ALT > 2 times normal range.
- •Liver histology revealing non-alcoholic steatohepatitis [NASH] (type 2-4), without cirrhosis.
- •Clinical characteristics of the metabolic syndrome as defined by the National Cholesterol Education Program (NCEP), but no overt diabetes.
- •Negative work-up for other causes of liver diseases including alcohol intake < 40 g/week.
排除标准
- •Diabetes mellitus.
- •Alcohol intake > 40 g per week.
结局指标
主要结局
histological and biochemical changes
次要结局
未报告次要终点