NCT00303537Unknown2 期
Double Blind, Randomized, Placebo Controlled Trial With Metformin in Non-Alcoholic Fatty Liver Disease (NAFLD)
University Hospital, Aker4 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2004年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Grade of steatosis as judged by repeat biopsy
研究概览
简要总结
The study evaluates the use of the antidiabetic medicine metformin in nonalcoholic fatty liver disease.
详细描述
Nonalcoholic fatty liver disease (NAFLD) is a prevalent disorder associated with insulin resistance. Metformin is a drug that has been used for several decades in the treatment of diabetes mellitus. Metformin is known to improve insulin sensitivity. Some authors have reported beneficial effects of metformin in NAFLD, others have not been able to reproduce these findings. Only a few randomized controlled studies have been published so far, and there is still need for controlled trials with sufficient power to assess the efficacy of metformin in this condition.
The aim of this study is to see whether treatment with metformin for 26 weeks results in reduction of liver steatosis (primary endpoint) and reduction in grade of inflammation in those with non-alcoholic steatohepatitis (NASH) (secondary endpoint).
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
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven NAFLD less than 18 months prior to inclusion. For those with pure steatosis, ALAT or aspartate aminotransferase (ASAT) must be elevated above the upper limits of normal, and impaired glucose tolerance or diabetes mellitus type 2 must be present.
- •Body weight within +/- 5 kg compared with the weight at the time of biopsy.
排除标准
- •Treatment for more than 1 week with metformin or glitazones the last 6 months before inclusion.
- •Treatment with insulin.
- •Hypersensitivity to metformin.
- •Treatment with cimetidine.
- •Heart failure requiring pharmacological treatment.
- •Coronary heart disease (New York Heart Association [NYHA] class 3 or 4).
- •Chronic obstructive lung disease (moderate or severe).
- •Breast-feeding or pregnant.
- •Metabolic acidosis.
- •Renal failure (male [♂]: creatinine > 135 micromol/L, female [♀] > 110 micromol/L).
- •Average alcohol consumption > 24 g/day the last year.
- •Serum ALAT or serum ASAT > 5 x upper limit of normal (ULN) at screening.
- •Cirrhosis.
- •Platelets < 100
- •Haemochromatosis.
- •Alfa-1-antitrypsin-deficiency.
- •Wilson's disease.
- •Thyroid dysfunction (0.2 mU/L < thyroid stimulating hormone [TSH] < 5.0 mU/L).
- •Chronic infection with hepatitis B or C virus or HIV.
- •Autoimmune hepatitis (antinuclear antibodies [ANA] > 1/256 or smooth muscle antibodies [SMA] > 1/128).
- •Primary biliary cirrhosis (antimitochondrial antibodies [AMA] > 1/64).
- •Primary sclerosing cholangitis.
- •Previous participation in another clinical trial the last 6 months.
- •Legal incapability.
结局指标
主要结局
Grade of steatosis as judged by repeat biopsy
时间窗: 6 mo
次要结局
- Serum alanine transaminase (ALAT)(6 mo)
- Grade of necroinflammation as judged by repeat biopsy(6 mo)
- Liver density obtained by computer scan(6 mo)
研究者
研究点 (4)
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