Observational cohort for non-alcoholic fatty liver disease and related conditions
PROtocol of Metabolic and Cryptogenic livEr Disease regisTry for intEgration of Omic Studies
This study is trying to learn more about non-alcoholic fatty liver disease and its related conditions by looking at patients with different stages of the disease and comparing them to people with diabetes and obesity who don't have it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma, Rome/lazio/italy) |
| Trial ID | NCT04371042 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a clinical phenotype of NAFLD or associated risk factors like diabetes and obesity.
Not a fit: Patients with a history of excessive alcohol consumption or those with Type 1 diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis, prognosis, and monitoring of liver disease and its comorbidities.
How similar studies have performed: Other studies have shown success in characterizing NAFLD and its complications, making this approach both relevant and promising.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Roma, Rome/lazio/italy
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.