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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 7300

Contacts and Locations

• Study Contact: Name: Maria Teresa Arias Loste, MD; Phone Number: 942202520; Email: mteresa.arias@scsalud.es

Study Locations

• Spain
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario Marques de Valdecilla
      • Contact: Maria Teresa Arias Loste, MD; Phone Number: 942204089

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all population

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Prevalence of NAFLD in patients with IMID; To analyze the global prevalence of NAFLD in patients with an immune-mediated inflammatory disease IMID
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
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
Genetic and Molecular characterization; Liver molecular characterization of NASH associated to IMID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of NAFLD in patients with IMID	Prevalence of NAFLD in patients with IMID	January 2019 - December 2020

Collaborators and Investigators

• Sponsor: Instituto de Investigación Marqués de Valdecilla
• Collaborators: Puerta de Hierro University Hospital; Hospital Universitario La Fe

Study record dates

Study Major Dates

• Study Start (Anticipated): January 7, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: November 29, 2018
• First Submitted That Met QC Criteria: November 29, 2018
• First Posted (Actual): November 30, 2018

Study Record Updates

• Last Update Posted (Actual): November 30, 2018
• Last Update Submitted That Met QC Criteria: November 29, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: PI18/01304

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No