Obesity Clinical Trial
— PROMETEOOfficial title:
PROtocol of Metabolic and Cryptogenic livEr Disease regisTry for intEgration of Omic Studies
NCT number | NCT04371042 |
Other study ID # | 2576 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 1, 2019 |
Est. completion date | December 31, 2035 |
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.
Status | Recruiting |
Enrollment | 5000 |
Est. completion date | December 31, 2035 |
Est. primary completion date | December 31, 2035 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Italy | Catholic University of Rome, Fondazione Policlinico Gemelli IRCCS | Roma | Rome/lazio/italy |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Registry creation | Set up an observational cohort with NAFLD at different stage of disease (from simple steatosis to cirrhosis and/or HCC) | 35 years |
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