Randomized Clinical Trial to Detect Advanced Fibrosis by Non-invasive Methods in Subjects With Non-alcoholic Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- Advanced Fibrosis by any diagnostic modality
研究概览
简要总结
The purpose of this randomized clinical trial is to evaluate the utility of noninvasive markers for the detection of advanced fibrosis in patients newly diagnosed with Non-alcoholic Fatty Liver Disease (NAFLD) by ultrasound.
The primary objective is to determine the effectiveness of noninvasive markers for detect of advanced fibrosis in patients with diagnosis of fatty liver disease.
The secondary objectives are:
- To determine the increase in health care with the specialist (gastroenterologist or endocrinologist).
- To determine which noninvasive evaluation strategy favors any treatment of fatty liver disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with BMI ≥ 27 Kg/m2 and any stage of non alcoholic fatty liver, diagnosed by ultrasound.
排除标准
- •Patients with other liver disease.
- •Patients under treatment with tamoxifen, methotrexate, amiodarone, diltiazem or other drugs able to induce fatty liver.
- •Patients with alcohol consumption greater than 140 gr. per week
- •Patients who have received blood transfusion before 1990
研究组 & 干预措施
Electronic detailed information
Standard of care for patients with diagnosis of fatty liver by ultrasound, plus electronic detailed information about non alcoholic fatty liver disease.
干预措施: Electronic detailed information (Other)
NAFLD Score
Standard of care for patients with diagnosis of fatty liver by ultrasound, plus electronic detailed information about non alcoholic fatty liver disease, plus diagnosis of advanced fibrosis by NAFLD score.
干预措施: Electronic detailed information (Other)
NAFLD Score
Standard of care for patients with diagnosis of fatty liver by ultrasound, plus electronic detailed information about non alcoholic fatty liver disease, plus diagnosis of advanced fibrosis by NAFLD score.
干预措施: NAFLD Score (Other)
NAFLD Score plus Transient elastography
Standard of care for patients with diagnosis of fatty liver by ultrasound, plus electronic detailed information about non alcoholic fatty liver disease, plus diagnosis of advanced fibrosis by NAFLD score and transient elastography.
干预措施: Electronic detailed information (Other)
NAFLD Score plus Transient elastography
Standard of care for patients with diagnosis of fatty liver by ultrasound, plus electronic detailed information about non alcoholic fatty liver disease, plus diagnosis of advanced fibrosis by NAFLD score and transient elastography.
干预措施: NAFLD Score (Other)
NAFLD Score plus Transient elastography
Standard of care for patients with diagnosis of fatty liver by ultrasound, plus electronic detailed information about non alcoholic fatty liver disease, plus diagnosis of advanced fibrosis by NAFLD score and transient elastography.
干预措施: Transient elastography (Other)
Transient elastography
Standard of care for patients with diagnosis of fatty liver by ultrasound, plus electronic detailed information about non alcoholic fatty liver disease, plus diagnosis of advanced fibrosis by transient elastography.
干预措施: Electronic detailed information (Other)
Transient elastography
Standard of care for patients with diagnosis of fatty liver by ultrasound, plus electronic detailed information about non alcoholic fatty liver disease, plus diagnosis of advanced fibrosis by transient elastography.
干预措施: Transient elastography (Other)
Standard of care
Standard of care for patients with diagnosis of fatty liver by ultrasound.
结局指标
主要结局
Advanced Fibrosis by any diagnostic modality
时间窗: One year after the diagnosis of steatosis.
Evidence of advanced fibrosis, diagnosed by transient elastography (greater than 8 kPa), NAFLD Score above 0.675, liver biopsy or any other non-invasive marker of liver fibrosis.
次要结局
- Specialized care(One year after the diagnosis of steatosis.)
研究者
Norberto Carlos Chavez Taia
Norberto Carlos Chavez-Tapia
Fundación Clínica Médica Sur