Main Hypothesis is That in the NASH Associated to IMIDs, to Different Phenotypes co Exist Clinical Trial
— INSTInCTOfficial title:
Immunomediated Non-alcoholic SteaTohepatitis; Prevalence and Characterization. INSTInCT Study
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.
Status | Not yet recruiting |
Enrollment | 7300 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario Marques de Valdecilla | Santander | Cantabria |
Lead Sponsor | Collaborator |
---|---|
Instituto de Investigación Marqués de Valdecilla | Hospital Universitario La Fe, Puerta de Hierro University Hospital |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of NAFLD in patients with IMID | Prevalence of NAFLD in patients with IMID | January 2019 - December 2020 |