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

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

— INSTInCT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03760172
• Other study ID #: PI18/01304
• Status: Not yet recruiting
• Start date: January 7, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2018
• Source: Instituto de Investigación Marqués de Valdecilla
• Contact: Maria Teresa Arias Loste, MD
• Phone: 942202520
• Email: mteresa.arias[@]scsalud.es
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Fatty Liver
• Main Hypothesis is That in the NASH Associated to IMIDs, to Different Phenotypes co Exist
• Non-alcoholic Fatty Liver Disease

Locations

Country	Name	City	State
Spain	Hospital Universitario Marques de Valdecilla	Santander	Cantabria

Sponsors (3)

Lead Sponsor	Collaborator
Instituto de Investigación Marqués de Valdecilla	Hospital Universitario La Fe, Puerta de Hierro University Hospital

Country where clinical trial is conducted

Spain, 

Outcome

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