Metformin Experience on Minimal Hepatic Encephalopathy in Patients With Liver Cirrhosis
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of patients with Minimal hepatic encephalopathy
研究概览
简要总结
Primary aim:
-To assess the effect of metformin use on the treatment of minimal hepatic encephalopathy in patients with liver cirrhosis.
Secondary aim:
-To evaluate if metformin is a safety drug in patients showing liver cirrhosis.
详细描述
In this study, 30 patients will be included divided in two arms. Investigators and patients will not know the treatment used (double blind).
Arm 1: Metformin 1000mg twice a day (2000 mg/day), during 12 weeks. Arm 2: Placebo 1000mg twice a day (2000mg/day), during 12 weeks.
At the end of the study, patients will be followed-up 8 weeks more to control the appearance of adverse effects.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with > 18 years old
- •Patients with the results of all the factors evaluable at the time of inclusion
- •Patients who have accepted their participation in the study through informed consent
- •Patients showing liver cirrhosis by ultrasound, transient elastography or liver biopsy
- •Patients showing minimal hepatic encephalopathy (PHES < 4 or Critical Flicker Frequency < 39 Hz)
排除标准
- •Patients with any contraindications to the drugs used
- •Patients showing type 1 diabetes mellitus
- •Patients showing type 2 diabetes mellitus and previous or current use of exogenous insulin, metformin or other oral antidiabetic drug
研究组 & 干预措施
Metformin
Patients receiving metformin
干预措施: Metformin (Drug)
Placebo
Patients receiving placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of patients with Minimal hepatic encephalopathy
时间窗: 12 weeks
Measurement of the results of critical flicker frequency after 12 weeks of metformin treatment
次要结局
- Number of patients with Minimal hepatic encephalopathy(12 weeks)