The Effect of Cigarette Smoking Reduction on Liver Function Tests and Metabolic Profile in Subjects With Non-alcoholic Steatohepatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Liver fat content percent change from baseline to 6 months
研究概览
简要总结
This non-randomized clinical trial was performed to clarify the effect of cigarette smoking reduction on liver function and some anthropocentric indices in smoker patients with non-alcoholic steatohepatitis.
详细描述
After excluding other causes of high aminotransferase level, participants with persistent elevated serum aminotransferase levels and evidence of fatty liver in ultrasonography were presumed to have non-alcoholic steatohepatitis. Those with NAFLD liver fat score greater than (-0.64) were enrolled. They were assigned to lifestyle modification alone or lifestyle modification plus smoking reduction groups.
Liver fat content, 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
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Smokers with persistent elevated aminotransferase levels with 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.
结局指标
主要结局
Liver fat content percent change from baseline to 6 months
时间窗: 6 months
Liver fat content percent changes calculated by a formula
次要结局
- Serum alanine aminotransferase level changes form baseline to 6 months(6 months)
研究者
Raika Jamali, MD
Associate Professor of Medicine
Tehran University of Medical Sciences