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临床试验/NCT03760172
NCT03760172Unknown不适用

Immunomediated Non-alcoholic SteaTohepatitis; Prevalence and Characterization. INSTInCT Study

Instituto de Investigación Marqués de Valdecilla1 个研究点 分布在 1 个国家目标入组 7,300 人开始时间: 2019年1月7日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
7,300
试验地点
1
主要终点
Prevalence of NAFLD in patients with IMID

研究概览

简要总结

NAFLD is a common comordidity in patients with IMID, including inflammatory bowel disease and psoriasis.

Nevertheless, the prevalence of NAFLD and NASH in the IMID population is not clear, and the risk factors are not completely understood. Interestingly, NASH and most of IMIDs share main molecular and immunological mechanisms of disease, as the inflammatory pathways depending on TNFa or imbalance in T cell subtypes like Th17/Treg. This common pathogenesis may explain, at least in a subset of patients, the development of NASH in the absence of classic metabolic risk factor.

Thus, our main hypothesis is that in the NASH assciated to IMIDs two different phenotypes co-exist.

First, a predominantly inflammatory phenotype, and not associated to the metabolic syndrome ande second, a predominantly metabolic phenptype, strongly associated to he metabolic syndrome.

In this way, we believe that in a particular subset of NAFLD patients, NASH could be considered as an IMID, as most of the definiting features of IMIDs are present. To demonstrate our hypothesis, we consider a two-stage study. First, we will determine the NAFLD and NASH prevalence in a cohort of well-characterized IMID patients and controls. Second, we will adress the molecular and immunophenotype characterization in liver biopsies of NASH patients with and without the co-existence of IMIDs.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

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

  • NAFLD with biopsy proven disease above 18 years
  • IMID patients above 18 years
  • All participants must give informed written consent

排除标准

  • Patients who had any clinical evidence of malignancy
  • Other secondary cause of chronic liver disease. Alternative causes of liver disease included excessive alcohol intake (higher than 20 g/day in women and 30 g/day in men), viral hepatitis, chronic alcohol consumption, autoimmune hepatitis, Wilson´s disease, alpha-1-antitripsine deficiency, inborn errors of metabolism or drug induced liver injury

结局指标

主要结局

Prevalence of NAFLD in patients with IMID

时间窗: January 2019 - December 2020

Prevalence of NAFLD in patients with IMID

次要结局

未报告次要终点

研究者

发起方
Instituto de Investigación Marqués de Valdecilla
申办方类型
Other
责任方
Principal Investigator
主要研究者

MARIA CINTA ALMENARA MIRAMON

Dr. Javier Crespo Garcia

Instituto de Investigación Marqués de Valdecilla

研究点 (1)

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