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

NCT03760172 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 7300

Last updated 2018-11-30

No results posted yet for this study

Summary

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.

Conditions

  • Main Hypothesis is That in the NASH Associated to IMIDs, to Different Phenotypes co Exist

Sponsors & Collaborators

  • Hospital Universitario La Fe

    collaborator OTHER

  • Puerta de Hierro University Hospital

    collaborator OTHER

  • Instituto de Investigación Marqués de Valdecilla

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-07
Primary Completion
2020-12-31
Completion
2021-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03760172 on ClinicalTrials.gov