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Clinical Trials/NCT03760172
NCT03760172UnknownNot Applicable

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

Instituto de Investigación Marqués de Valdecilla1 site in 1 country7,300 target enrollmentStarted: January 7, 2019Last updated:
Conditions

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

Sponsor
Instituto de Investigación Marqués de Valdecilla
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

MARIA CINTA ALMENARA MIRAMON

Dr. Javier Crespo Garcia

Instituto de Investigación Marqués de Valdecilla

Study Sites (1)

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