Immunomediated Non-alcoholic SteaTohepatitis; Prevalence and Characterization. INSTInCT Study
NCT ID: NCT03760172
Last Updated: 2018-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
7300 participants
OBSERVATIONAL
2019-01-07
2021-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Prevalence of NAFLD in patients with IMID
To analyze the global prevalence of NAFLD in patients with an immune-mediated inflammatory disease IMID
No interventions assigned to this group
Prevalence of High-risk NASH in patients with IMID
To evaluate the prevalence of high-risk NASH (NASH with advanced fibrosis) in patients with IMID through clinical, radiological and histological evaluation
No interventions assigned to this group
Immunophenptypic characterization
To investigate the existence of common and differential immunophenotypes between the subjects with NASH with and without IMID, and patients with IMID without liver involment
No interventions assigned to this group
Genetic and Molecular characterization
Liver molecular characterization of NASH associated to IMID
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* IMID patients above 18 years
* All participants must give informed written consent
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Hospital Universitario La Fe
OTHER
Puerta de Hierro University Hospital
OTHER
Instituto de Investigación Marqués de Valdecilla
OTHER
Responsible Party
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MARIA CINTA ALMENARA MIRAMON
Dr. Javier Crespo Garcia
Locations
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Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Countries
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Central Contacts
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Facility Contacts
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Maria Teresa Arias Loste, MD
Role: primary
Other Identifiers
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PI18/01304
Identifier Type: -
Identifier Source: org_study_id