The Effect of Pentoxifylline on Liver Function Tests in Non-alcoholic Fatty Liver Disease Patients Refereed to Sina Hospital Gastroenterology Clinic
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change from baseline serum alanine aminotransferase at 6 months
研究概览
简要总结
This randomized double blind clinical trial was performed in patients with non-alcoholic fatty liver disease.They were randomly assigned to lifestyle modification alone or lifestyle modification plus Pentoxifylline groups. Liver function tests, metabolic profile and anthropometric measurements were checked at baseline and six months later.
详细描述
This randomized double blind clinical trial was performed in patients with the evidence of fatty liver in ultrasonography. After excluding other causes, participants with persistent elevated serum aminotransferase levels were presumed to have NAFLD. Those with NAFLD liver fat score greater than (-0.64) were enrolled. They were randomly assigned to lifestyle modification alone or lifestyle modification plus Pentoxifylline groups. Fasting serum glucose, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, triglyceride, cholesterol, high and low-density lipoprotein,homeostasis model assessment-insulin resistance(HOMA-IR), and anthropometric measurements (body mass index and waist circumference) were checked at baseline and six months later.
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 (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with persistent elevated aminotransferase levels and the evidence of fatty liver in ultrasonography, who were referred to a gastroenterology clinic.
排除标准
- •alcohol use (more than 20 gram per day in men and 10 gram per day in women per day),
- •heart disease (ischemic or congestive),
- •hepatic disease (viral hepatitis, autoimmune hepatitis, wilson disease, hemochromatosis, liver mass lesion),
- •renal disease (serum creatinine concentration of > 1.5 mg/dl),
- •any severe systemic co-morbidities, neoplasm,
- •using any hepatotoxic medication during the past 3 months,
- •pregnant or lactating women.
研究组 & 干预措施
Pentoxifylline + lifestyle modification
Pentoxifylline for 6 months plus obtaining ideal body weight by calorie restriction diet and programmed physical activity.
干预措施: Pentoxifylline (Drug)
Pentoxifylline + lifestyle modification
Pentoxifylline for 6 months plus obtaining ideal body weight by calorie restriction diet and programmed physical activity.
干预措施: Lifestyle modification (Behavioral)
Lifestyle modification
Obtaining ideal body weight by calorie restriction diet and programmed physical activity.
干预措施: Lifestyle modification (Behavioral)
结局指标
主要结局
Change from baseline serum alanine aminotransferase at 6 months
时间窗: 6 months
次要结局
- Change from baseline serum aspartate aminotransferase at 6 months(6 months)
研究者
Raika Jamali, MD
Associate Professor of Medicine
Tehran University of Medical Sciences