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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03760172
Acronym
INSTInCT
Enrollment
7300
Registered
2018-11-30
Start date
2019-01-07
Completion date
2021-12-31
Last updated
2018-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

None listed

Sponsors

Hospital Universitario La Fe
CollaboratorOTHER
Puerta de Hierro University Hospital
CollaboratorOTHER
Instituto de Investigación Marqués de Valdecilla
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of NAFLD in patients with IMIDJanuary 2019 - December 2020Prevalence of NAFLD in patients with IMID

Countries

Spain

Contacts

Primary ContactMaria Teresa Arias Loste, MD
mteresa.arias@scsalud.es942202520

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026