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临床试验/NCT04573543
NCT04573543已完成不适用

The Role of Immune Semaphorins in NAFLD

University Hospital for Infectious Diseases, Croatia1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
160
试验地点
1
主要终点
Detection of semaphorins in patients with NAFLD

研究概览

简要总结

To goal is to identify semaphorins that are associated with NAFLD and to investigate their relationship with variable degrees of steatosis and fibrosis.

详细描述

Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease associated with systemic changes in immune response. Semaphorins were recently recognized as one of the key regulators of immune responses; while some suppress immune cells activation, proliferation, and production of inflammatory cytokines, others stimulate immune responses. We have previously shown that semaphorins are associated with pathogenesis of viral hepatitis and progression of fibrosis. However, their role in NAFLD is unknown. The hypothesis of this project is that semaphorins are regulators of inflammation in patients with NAFLD. This study is designed as a prospective, non-interventional study. The main aims are: (1) to analyze serum concentration of semaphorins in patients with NAFLD; (2) to analyze tissue expression of semaphorins in patients with NAFLD; (3) to analyze semaphorin gene polymorphisms associated with NAFLD. Semaphorins could be a novel diagnostic and prognostic biomarker as well as targets for immune modulation.

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients diagnosed with NAFLD according to current guidelines (AASLD, EASL)

排除标准

  • •Immunosuppression
  • •Malignancies
  • •Autoimmune diseases
  • •Pregnancy
  • •Chronic viral hepatitis
  • •Presence of other chronic liver disease (hemochromatosis, Wilson's disease, toxic hepatitis, deficiency of alpha-1-antitrypsin, liver autoimmune disease)
  • •Consumption of alcohol > 20 g/day

结局指标

主要结局

Detection of semaphorins in patients with NAFLD

时间窗: 12 months

Measurement of semaphorins concentration in serum of patients with NAFLD by enzyme-linked immunosorbent assay (ELISA)

Identification of semaphorin gene polymorphism in patients with NAFLD

时间窗: 12 months

Sequencing of semaphorin genes in patients with NAFLD using Sanger sequencing

次要结局

  • Staging of liver steatosis(12 months)
  • Staging of liver fibrosis(12 months)

研究者

发起方
University Hospital for Infectious Diseases, Croatia
申办方类型
Other
责任方
Sponsor

研究点 (1)

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