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临床试验/NCT02206841
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

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

发起方
Seoul National University Boramae Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Won Kim

M.D, PhD

Seoul National University Boramae Hospital

研究点 (1)

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