NCT03760172: INSTInCT

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

Status unknown Last updated 30 November 2018

What this trial tests

trial in Main Hypothesis is That in the NASH Associated to IMIDs, to Different Phenotypes co Exist in 7,300 participants. Status unknown.

Timeline

7 January 2019

Primary endpoint
31 December 2020

31 December 2021

Quick facts

Lead sponsor	Instituto de Investigación Marqués de Valdecilla
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	7,300
Start date	7 January 2019
Primary completion	31 December 2020
Estimated completion	31 December 2021
Sites	1 location across Spain

Conditions studied

• Main Hypothesis is That in the NASH Associated to IMIDs, to Different Phenotypes co Exist — all drugs for Main Hypothesis is That in the NASH Associated to IMIDs, to Different Phenotypes co Exist →

Sponsor

Instituto de Investigación Marqués de Valdecilla — full company profile →

Who can join

18 and older, any sex, with Main Hypothesis is That in the NASH Associated to IMIDs, to Different Phenotypes co Exist. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical and molecular characterization of steatotic liver disease in the setting of immune-mediated inflammatory diseases.
   García-Nieto E, Rodriguez-Duque JC, Rivas-Rivas C, Iruzubieta P, et al · · 2024 · cited 3× · PMID 39411649 · DOI 10.1016/j.jhepr.2024.101167
2. Prevalence of antinuclear antibodies in inflammatory bowel disease and seroconversion after biological therapy.
   García MJ, Rodríguez-Duque JC, Pascual M, Rivas C, et al · · 2022 · cited 3× · PMID 35251307 · DOI 10.1177/17562848221077837