Observational cohort for non-alcoholic fatty liver disease and related conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to establish an observational cohort of patients with non-alcoholic fatty liver disease (NAFLD) at various stages, from simple steatosis to cirrhosis and hepatocellular carcinoma (HCC). It will also include a comparative cohort of individuals with diabetes, obesity, and other risk factors who do not have NAFLD. Clinical data, biological samples, and imaging results will be collected to elucidate disease pathways and develop biomarkers for diagnosis and monitoring. The ultimate goal is to contribute to precision medicine in liver disease management.

Why it matters

Who can join: the full rules

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.

Where it's running

• Catholic University of Rome, Fondazione Policlinico Gemelli IRCCS
  Roma, Rome/lazio/italy, Italy Recruiting

Study contacts

• Study coordinator: LUCA MIELE, MD, PhD
• Email: luca.miele@policlinicogemelli.it; luca.miele@unicatt.it
• Phone: +390631051

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.