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临床试验/NCT05907408
NCT05907408尚未招募不适用

Precision Medicine in Fatty Liver Disease: How to Identify the Patient Who Develops Steatohepatitis Using Omics Techniques

Universidade Federal do Rio de Janeiro1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
10
试验地点
1
主要终点
Steatosis, without fibrosis or inflammation

研究概览

简要总结

Nonalcoholic steatohepatitis (NASH) is the most common cause of chronic liver disease in Western countries and one of the leading causes of liver transplantation in the world. Its spectrum ranges from simple steatosis to decompensated cirrhosis, resulting from progressive fibrosis due to inflammation and cellular injury. The reasons why patients with the same degree of steatosis have different evolutions are not sufficiently known. The objective of this project is to identify biomarkers that predict disease progression, using omics techniques, which can serve to develop new therapeutic strategies.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Metabolic syndrome
  • Liver steatosis detected on transient hepatic elastography performed in the last 12 months
  • Steatosis with or without fibrosis confirmed histologically in a liver biopsy performed in the last 12 months

排除标准

  • Concurrent liver disease (other than NAFLD)
  • Chronic or prolonged use of any potential hepatotoxic drug or substance
  • HIV infection
  • Cancer (except basal cell carcinoma)

结局指标

主要结局

Steatosis, without fibrosis or inflammation

时间窗: 12 months

Patients with non-alcoholic fatty liver disease presenting exclusively with steatosis, without fibrosis or inflammation

Steatohepatitis, with fibrosis

时间窗: 12 months

Patients with non-alcoholic fatty liver disease presenting with steatosis and degree \>1 of liver fibrosis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guilherme Rezende

Associate Professor

Universidade Federal do Rio de Janeiro

研究点 (1)

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