Observational cohort studying fatty liver disease and related metabolic conditions
Collects clinical data and samples from adults with fatty liver disease, diabetes or obesity.
Key facts
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Where
- Roma, ItalySee the site
- Trial code
- Registry title
- PROtocol of Metabolic and Cryptogenic livEr Disease regisTry for intEgration of Omic Studies
- Status
- Recruiting
- People taking part
- 5,000 people, planned
- Started
- 1 Sept 2019
- Expected to end
- 31 Dec 2035
- Type of study
- Observational
- Record updated
- 1 May 2020
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with fatty liver disease at any stage, from simple fat in the liver to cirrhosis or liver cancer. It also looks for people with diabetes, obesity or similar risk factors but no fatty liver.
- Age
- 18 years or older
- Sex
- All
- Disease stage
- Fatty liver disease (NAFLD) at any stage: simple steatosis, NASH, metabolic cirrhosis or NAFLD-related liver cancer (HCC). Or risk factors for NAFLD (such as diabetes, metabolic syndrome, obesity, psoriasis) with no fatty liver on ultrasound.
- Earlier treatment
- People who cleared hepatitis C infection with new DAAs drugs can join if the sustained virological response lasted more than 6 months.
- Biomarker or test result
- Fatty liver shown by liver biopsy, or by blood test and/or imaging results consistent with NAFLD.
Main reasons for not taking part
- Average alcohol intake above 21 units a week (men) or 14 units a week (women) in the last 6 months
- History of sustained excessive alcohol use in the past 5 years
- History or presence of type 1 diabetes
- Refusal or inability to give informed consent
- Judged unsuitable by the investigator
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Refusal or inability (lack of capacity) to give informed consent
- Patients not meeting inclusion criteria or judged by the investigator to be unsuitable for inclusion in the study
Where in Italy
- Catholic University of Rome, Fondazione Policlinico Gemelli IRCCSRoma, ItalyContact: Luca Miele, MD PhDTaking people
About the trial
What the trial wants to find out
The main aim of the study is to set up an observational cohort with NAFLD (Non-alcoholic fatty liver disease) at different stage of disease (from simple steatosis to cirrhosis and/or HCC-Hepatocellular carcinoma) and for comparative purpose a cohort of subjects with diabetes and/or obesity and/or other risk factors (i.e. psoriasis, IBD (inflammatory bowel disease), dyslipidemia) without NAFLD in order to have a clinical phenotypical characterization and the collection of biological specimens.
Read full original descriptionShow less
We will collect clinical data, biological samples and imaging results in order to perform future cross-sectional studies and/or longitudinal studies for elucidating pathways of the disease and develop and validate biomarkers for diagnosis, prognosis and monitoring liver disease and comorbidities in order to contribute to precision medicine in this field.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- PROtocol of Metabolic and Cryptogenic livEr Disease regisTry for intEgration of Omic Studies
- Plain-language title
- Observational cohort studying fatty liver disease and related metabolic conditionsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 1 May 2020