Comparison of the Effects of Metformin and Pioglitazone on Liver Enzymes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Liver transaminase levels
研究概览
简要总结
BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is a spectrum of hepatic disease ranging from fat accumulation in liver to fibrosis and cirrhosis. It affects 25% of the world population on average. Objective of this study is to compare the effect of metformin (1000 milligrams daily) versus pioglitazone (30 milligrams daily) in improving liver transaminases and ultrasound changes in non-diabetic patients of NAFLD when given for six months.
METHODS: A Quasi-experimental study was conducted in Mayo Hospital Lahore from October 2019 to November 2020.Out of 96 half Patients were assigned randomly to Group-A (metformin) or Group-B (pioglitazone). Demographic history, abdominal ultrasound & liver enzymes were recorded on Proforma monthly till 6 months. Data was put into and analyzed by SPSS version 26; t-test was used to compare the mean liver transaminases between the two groups. Ultrasound findings were compared by Chi square. The P value of less than 0.05 was counted as significant.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gender: Both male and female
- •Age: 18-80 Years
- •Ultrasound evidence of fatty liver as per operational definition
- •Liver enzymes as per operational definition
排除标准
- •Cirrhotic patients as per operational definition
- •Chronic Hepatitis B or chronic hepatitis C
- •Patients taking long term steroids, highly active antiretroviral therapy, diltiazem, irinotecan, oxaliplatin and amiodarone
- •Patients taking alcohol (based on history and AST to ALT ratio)
- •Patients with heart failure (NYHA Classification class III or IV status: patients comfortable at rest but less than ordinary physical activity causes undue fatigue, dyspnea or palpitations)
- •Patients with renal failure (serum creatinine ≥ 1.4 mg% or eGFR < 45 ml/min/1.73 m2)
研究组 & 干预措施
Metformin Group
Group-A; every participant took 500 mg of metformin daily
干预措施: Metformin and Pioglitazone (Drug)
Pioglitazone Group
Group-B; every participant took 30 mg of pioglitazone daily
干预措施: Metformin and Pioglitazone (Drug)
结局指标
主要结局
Liver transaminase levels
时间窗: The comparison is done after 6 months of drug treatment
There should be a 22% or more change in transaminases levels from baseline.
次要结局
- Fatty Liver Grade(The comparison is done after 6 months of drug treatment)
研究者
Mohammad Ibrahim
Postgraduate Resident of Internal Medicine
King Edward Medical University