PROtocol of Metabolic and Cryptogenic livEr Disease regisTry for intEgration of Omic Studies

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Apr 28, 2020

Keywords

ClinConnect Summary

This clinical trial is focused on understanding Nonalcoholic Fatty Liver Disease (NAFLD), which can lead to serious conditions like cirrhosis and liver cancer. The researchers aim to create a group of participants with various stages of NAFLD and compare them with individuals who have diabetes, obesity, or other related health issues but do not have fatty liver disease. By gathering information about patients’ health, biological samples, and imaging results, the study hopes to find better ways to diagnose and monitor liver disease and its related health problems.

To be eligible for this trial, participants need to be at least 18 years old and have been diagnosed with NAFLD or have certain risk factors like diabetes or obesity. They should not have a history of heavy alcohol use and must have cleared any past hepatitis C infections. Participants can expect to contribute to important research that may improve how liver diseases are understood and treated in the future. The trial is currently recruiting individuals of all genders, and participation will involve sharing health information and samples over time.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years
• * Clinical phenotype of NAFLD (simple steatosis, NASH, metabolic cirrhosis, NAFLD-HCC) based on any of:
• • Liver biopsy providing histological evidence of NAFLD or,
• • Biochemical and/or radiological findings consistent with NAFLD
• • Average alcohol consumption ≤21/14 units/week (males/females) in preceding 6 months and no history of sustained excessive consumption of alcohol in past 5 years.
• • Clearance of HCV infection with new DAAs drugs with a SVR (sustained virological response) period \> 6 months
• • Presence of risk factors for NAFLD (i.e. diabetes, metabolic syndrome, obesity, psoriasis) and absence of fatty liver at US
• Exclusion Criteria:
• • Refusal or inability (lack of capacity) to give informed consent.
• • Average alcohol ingestion \>21/14 units/week (males/females) in preceding 6 months or history of sustained excessive consumption of alcohol in past 5 years.
• • History or presence of Type 1 diabetes mellitus.
• • Patients not meeting inclusion criteria or judged by the investigator to be unsuitable for inclusion in the study.