Assessment of Endothelial Function in Patients With Non Alcoholic Fatty Liver Disease and the Impact of Statin Treatment
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change from baseline in liver steatosis at 6 months
研究概览
简要总结
The aim of the current study is to evaluate the association of fatty liver severity and endothelial function in Non-Alcoholic Fatty Liver Disease (NAFLD) patients and to find the impact of statin treatment compared to usual care or life style modification on endothelial function, liver steatosis and fibrosis.
详细描述
The study cohort will include 150 patients with fatty liver per ultrasound or histology. The patients will be divided randomly to one of three arms: follow up group, lifestyle modification group, and statins therapy (Atorvastatin 20mg/d for 6 months). at screening, after 6 months (end of treatment), and 12 months the patients will undergo:
- complete physical examination
- blood pressure measurement
- assessment of height and weight, body mass index and waist circumference
- blood samples for complete blood count, fasting plasma glucose, fasting plasma insulin, lipid profile, liver enzymes, albumin, bilirubin, Prothrombin time (PT INR), Hemoglobin A1c, ferritin, adiponectin, C-reactive protein, Tumor necrosis factor alpha, Lipoprotein-phospholipase A2, Apolipoproteins B100, A1, C3, C4, ceruloplasmin
- Liver elastography and sonographic liver fat quantification
- Brachial artery flow-mediated dilatation (FMD) measurement
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
- 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
- •subjects willing to comply with study requirements and have signed an informed consent form
- •fatty liver per abdominal ultrasound or liver biopsy
排除标准
- •alcohol drinking >140g/week
- •presence of hepatitis B or C or HIV
- •known liver disease other than fatty liver
- •usage of drugs known to cause liver steatosis
- •subjects with known allergies or hypersensitivity to statins
- •subjects with known cardiovascular/cerebrovascular disease
- •subjects with known dyslipidemia requiring drug treatment
- •subjects with diabetes mellitus
- •history of drug or alcohol abuse
- •refusal to sig the informed consent form
研究组 & 干预措施
Statin
statin therapy (atorvastatin 20 mg/d) for 6 months
干预措施: atorvastatin (Drug)
lifestyle counseling
lifestyle modification by dietician counseling and follow-up
干预措施: lifestyle counseling (Behavioral)
结局指标
主要结局
Change from baseline in liver steatosis at 6 months
时间窗: baseline, 6 months and 12 months
Impact of statin treatment(which will be given for 6 months) compared to no intervention or lifestyle modification on liver steatosis and fibrosis. Liver steatosis will be assessed by sonographic liver fat quantification (hepatorenal sonographic index.
change from baseline in liver fibrosis at 6 months
时间窗: baseline, 6 months and 12 months
Impact of statin treatment(which will be given for 6 months) compared to no intervention or lifestyle modification on liver fibrosis. Liver fibrosis will be assessed by Real-Time shear wave elastography.
次要结局
- relationship between blood parameters and endothelial function(at diagnosis and after 6 months and 12 months)
- endothelial function in Non-Alcoholic Fatty Liver Disease (NAFLD) patients(12 months)
- relationship between blood parameters and liver steatosis and fibrosis(12 months)
- change from baseline in endothelial function at 6 months(at diagnosis 6 months and 12 months)
研究者
Prof. Ziv Ben-Ari MD
Head of Disease Medical Center
Sheba Medical Center