Status:
RECRUITING
PROtocol of Metabolic and Cryptogenic livEr Disease regisTry for intEgration of Omic Studies
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
NAFLD - Nonalcoholic Fatty Liver Disease
Diabetes
Eligibility:
All Genders
18+ years
Brief Summary
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-Hepatocellula...
Detailed Description
Non-alcoholic fatty liver disease (NAFLD) is characterized by the excessive accumulation of triglycerides in the liver and is often associated, in the absence of significant alcohol consumption, to in...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2035
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT04371042
Start Date
September 1 2019
End Date
December 31 2035
Last Update
May 1 2020
Active Locations (1)
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1
Catholic University of Rome, Fondazione Policlinico Gemelli IRCCS
Roma, Rome/lazio/italy, Italy, 00168