NCT02206841招募中不适用
Establishment of Non-alcoholic Fatty Liver Disease Cohort and Development of Markers to Predict Histologic Progression of Liver Fibrosis
Seoul National University Boramae Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2014年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- histologic steatosis and fibrosis grade
研究概览
简要总结
This study is designed for establishment of non-alcoholic fatty liver disease patients cohort to development of markers to predict histologic progression of liver fibrosis.
详细描述
- Acoustic radiation force impulse elastography and transient elastography
- Liver tissue (frozen tissue, paraffin block)
- Whole blood, Serum
- Fat amount ratio CT (Visceral adipose tissue, Subcutaneous adipose tissue amount)
- Body composition analyzer (InBody scale):Total fat/muscle mass and appendicular skeletal muscle mass
- Pulmonary function test with post-bronchodilator response and DLCo
- EKG, EchoCG, Heart CT (Coronary calcium score), and Pusle wave velocity (AI index, arterial stiffness)
- Brain MRI or CT
- Upper esophagogastroscopy and colonoscopy
- Berlin score questionnaire and Polysomnography
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 histologically confirmed fatty liver disease
- •Patients with radiologically confirmed fatty liver disease
排除标准
- •History of significant alcohol consumption
- •Viral hepatitis
- •Autoimmune hepatitis
- •Metabolic diseases (e.g. hemochromatosis, M. Wilson, alpha 1-antitrypsin deficiency)
- •Hepatotoxic medication (e.g. amiodarone)
结局指标
主要结局
histologic steatosis and fibrosis grade
时间窗: baseline
We will evaluate fibrosis using laboratory examination, radiologic evaluation and liver tissue pathology.
次要结局
- Development of markers for hepatic fibrosis progression(baseline and every 6 months (up to 1year))
研究者
Won Kim
M.D, PhD
Seoul National University Boramae Hospital
研究点 (1)
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