Aspirin in Adults With Nonalcoholic Fatty Liver Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Absolute Change in Intrahepatic Lipid Content, by 1H-MRS
研究概览
简要总结
Nonalcoholic fatty liver disease (NAFLD), defined by fatty infiltration of the liver in the absence of excess alcohol consumption, affects an estimated 30% of adults in the United States. A proportion of people with NAFLD will develop progressive, inflammatory nonalcoholic steatohepatitis (NASH), which can progress to liver cirrhosis and liver failure. NAFLD is expected to be the most common indication for liver transplantation by the year 2020. We hypothesize that among adults with NAFLD, aspirin will reduce intrahepatic lipid content, as quantified by 1H magnetic resonance spectroscopy (1H-MRS).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Ages 18 to 70 years
- •NAFLD, defined by confirmed hepatic steatosis by imaging or by liver biopsy, in the absence of other causes of hepatic steatosis or significant alcohol consumption. If liver imaging or biopsy has not been performed clinically, liver ultrasound assessment will be performed as part of the screening visit.
- •Early-stage liver fibrosis, defined as fibrosis less than or equal to Fibrosis Stage 3 (F3), confirmed by either (1) a recent liver biopsy or (2) a recent elastography / Fibroscan study. If no recent biopsy or elastography/Fibroscan have been performed, a Fibroscan will be performed as part of the screening visit.
排除标准
- •Liver fibrosis stage > 3
- •Current aspirin use
- •Contraindications to aspirin use
- •Contraindications to magnetic resonance imaging (MRI)
- •Pregnancy or desire to become pregnant
- •Breastfeeding
研究组 & 干预措施
Aspirin
Low-dose (81mg) aspirin tablets
干预措施: Aspirin 81 mg (Drug)
Placebo
Placebo tablets
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Absolute Change in Intrahepatic Lipid Content, by 1H-MRS
时间窗: 6 months
Absolute percentage change in intrahepatic lipid content, quantified by 1H-MRS
次要结局
- Relative Change in Intrahepatic Lipid Content(6 months)
研究者
Tracey G. Simon, MD
Instructor in Medicine and Gastroenterology
Massachusetts General Hospital