Observational cohort studying fatty liver disease and related metabolic conditions
Collects clinical data and samples from adults with fatty liver disease, diabetes or obesity.
Plain-language title generated from the registry record
Registry title: PROtocol of Metabolic and Cryptogenic livEr Disease regisTry for intEgration of Omic Studies
Key facts
- Where
- Roma, ItalySee the site
Where in Italy
- Catholic University of Rome, Fondazione Policlinico Gemelli IRCCSRoma, ItalyTaking people
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?
Trial details
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Trial code
- NCT04371042
- Record updated
- 1 May 2020
- Original description
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
PROtocol of Metabolic and Cryptogenic livEr Disease regisTry for intEgration of Omic Studies
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.
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.
Inclusion: 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: 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.