Immunomediated Non-alcoholic SteaTohepatitis; Prevalence and Characterization. INSTInCT Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 7,300
- Locations
- 1
- Primary Endpoint
- Prevalence of NAFLD in patients with IMID
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Prevalence of NAFLD in patients with IMID
Time Frame: January 2019 - December 2020
Prevalence of NAFLD in patients with IMID
Secondary Outcomes
No secondary outcomes reported
Investigators
MARIA CINTA ALMENARA MIRAMON
Dr. Javier Crespo Garcia
Instituto de Investigación Marqués de Valdecilla
