Immunomediated Non-alcoholic SteaTohepatitis; Prevalence and Characterization. INSTInCT Study
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
- 是
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
MARIA CINTA ALMENARA MIRAMON
Dr. Javier Crespo Garcia
Instituto de Investigación Marqués de Valdecilla
