NCT00134303已完成4 期
Double Blinded Randomised Trial Comparing Metformin Versus Placebo in NASH Patients Receiving Bariatric Surgery for Obesity
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Number of patients with histological amelioration of NASH after a period of 1 year
研究概览
简要总结
This is a comparison of metformin versus placebo in NASH patients receiving bariatric surgery for obesity.
详细描述
In patients receiving bariatric surgery, a preoperative liver biopsy will confirm the presence of NASH. Those patients with NASH (histologically defined according the Brunt's criteria) will be randomized to receive metformin (2 times 850 mg orally daily) or placebo for a time period of 1 year. A control liver biopsy will be performed after one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients receiving bariatric surgery for obesity
排除标准
- •Other causes of liver disease (hepatitis B virus [HBV], hepatitis C virus [HCV], primary biliary cirrhosis [PBC], etc.)
- •Patients with diabetes type I
- •Patients with endocrinological reasons for obesity (eg. Cushing, etc.)
研究组 & 干预措施
NASH
Experimental
干预措施: Metformin (Drug)
结局指标
主要结局
Number of patients with histological amelioration of NASH after a period of 1 year
时间窗: 1 year
次要结局
- Number of patients with normalisation of ALT, steatosis on ultrasound after a period of 1 year(1 year)
研究者
研究点 (1)
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