Recall of a Cohort of Subjects in the Mediterranean Area. Monitoring of Liver Diseases (NUTRIHEP 3).

ConditionCohort Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

About this trial

Liver diseases represent a significant public health problem, with a high prevalence and a growing incidence worldwide, and a significant impact on global morbidity and mortality, causing approximately 2 million deaths annually.

Deaths are largely attributable to complications of cirrhosis and hepatocellular carcinoma.

The most common causes of cirrhosis worldwide are related to viral hepatitis, alcohol, and non-alcoholic fatty liver disease caused by poor dietary habits.

Regarding the hepatitis B virus (HBV), the vaccination program, together with the improvement of socioeconomic conditions and greater public awareness, have progressively reduced the incidence and prevalence of this viral disease. Chronic hepatitis related to the hepatitis C virus (HCV), after an increase in the 1980s and 1990s, is showing a decreasing trend, particularly among younger age groups. While other studies have focused on liver diseases of metabolic origin, the most recent epidemiological data concerning the Italian population were collected in the late 1990s. Since a decade has now passed, it was thought that it might be interesting to collect new data on the prevalence pattern of liver diseases, especially in southern Italy, particularly in a municipality equally geographically distant from both the coast and the inland. Therefore, this observational study aims to analyze the evolution of liver diseases through the recall of a cohort of patients already identified in the Mediterranean area. The cohort is composed of individuals residing in the municipality of Putignano (BA) who have already undergone evaluation of liver function, comorbidities and dietary habits, in addition to adding genetic information through genome-wide association (GWAS) analyses, useful for identifying associations between genetic variants and specific phenotypic characteristics

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

>18 Years

Resident of Putignano (BA -Italy)

Disqualifiers

< 18 years

Trial population

The NUTRIHEP cohort (Putignano) was first established in 2006-2007, comprising a cohort of 2300 subjects, recalled from the lists of general practitioners in the municipality of Putignano (BA) with a 1:3 step. In 2015-2018, the same subjects were recalled, with a follow-up adherence of 65.60%. Furthermore, 102 deaths were recorded from 2007 to 2014. The recall will consider the 2300 from the 1st wave, from which the deaths evaluated through the consultation of the Death Registers via the regional EDOTTO system and those who moved to other regions will be subtracted.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Elaboration of Poligenic Risk

Identification of SNP groups associated with liver disease to construct a polygenic risk score

Time frame
36 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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