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临床试验/NCT02947568
NCT02947568Unknown不适用

Genetical Background of Non-alcoholic Fatty Liver Disease (NAFLD) in Diabetes Mellitus and in Chronic Kidney Disease

University of Pecs1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
600
试验地点
1
主要终点
Association of genetical factors with NFS and HSI

研究概览

简要总结

The present study investigates relationship between non-alcoholic fatty liver disease and its risk factors, such as genetic background and diseases, such as chronic kidney disease and diabetes mellitus.

详细描述

Non-alcoholic fatty liver disease (NAFLD) is a multisystemic disease, also affecting extrahepatic organs (1,2,6). According to former data, not only the prevalence of chronic hepatic disease, chronic cardiovascular diseases, but also the prevalence of chronic kidney disease (CKD) is higher in NAFLD (4,7). A strong association has been shown between diabetes mellitus (DM) and NAFLD as well (3,5,10).

Many genetical factors have been studied in the background of NAFLD. Many studies have proved the effect of patatin-like phospholipase domain-containing protein 3 gene (PNPLA3) (8,9). Effect of numerous genetical polymorphisms has been suggested behind oxidative stress responsible for NAFLD (8).

研究设计

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

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • CKD (renal replacement therapy non excluded)

排除标准

  • alcohol abuse

结局指标

主要结局

Association of genetical factors with NFS and HSI

时间窗: 2 years

The association of hepatic steatosis with genetic factors will be assessed. In case of patatin-like phospholipase domain-containing protein 3 gene (PNPLA3) : rs738409, rs2281135, rs2294918 single nuclear polimorfism (SNP) will be examined

Association of NFS (NAFLD fibrosis score) and HSI (hepatic steatosis index) with underlying conditions

时间窗: 2 years

The association of hepatic steatosis with chronic kidney disease, diabetes mellitus and the the persence of these two will be assessed

次要结局

  • Association of glucose metabolism parameters with hepaic steatosis indices(2 years)
  • The relationship between blood count, sedimentation and inflammation with hepatic setatosis indices(2 years)
  • Association of liver function and hepatic setatosis indices(2 years)
  • Assotion of serum proteins with hepatic setatosis indices(2 years)
  • Association of iron metabolism parameters with hepatic setatosis indices(2 years)
  • Association of pathological tyrosine isoforms with hepatic setatosis indices(2 years)
  • Association of hepatic steatosis with renal function(2 years)
  • Association of serum lipid profile and hepatic setatosis indices(2 years)

研究者

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

Dr. Gergő Molnár

MD

University of Pecs

研究点 (1)

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