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

NCT06931925 | Not Yet Recruiting

• 1 other identifier: Nutrihep3
• Study Type: observational
• Target: 2,300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Cohort Study

Keywords

Cohort Study; GWAS; MASLD; Liver Diseases

Outcome Measures

Primary Outcomes (1)

• Elaboration of Poligenic Risk

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

  36 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• \>18 Years
• Resident of Putignano (BA -Italy)

You may not qualify if:

• \< 18 years

Sponsors & Collaborators

• Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis: lead

Related Publications (3)

• Devarbhavi H, Asrani SK, Arab JP, Nartey YA, Pose E, Kamath PS. Global burden of liver disease: 2023 update. J Hepatol. 2023 Aug;79(2):516-537. doi: 10.1016/j.jhep.2023.03.017. Epub 2023 Mar 27.

  PMID: 36990226 BACKGROUND

• Stroffolini T. The changing pattern of hepatitis B virus infection over the past three decades in Italy. Dig Liver Dis. 2005 Aug;37(8):622-7. doi: 10.1016/j.dld.2005.02.010.

  PMID: 15996630 BACKGROUND

• Bedogni G, Miglioli L, Masutti F, Tiribelli C, Marchesini G, Bellentani S. Prevalence of and risk factors for nonalcoholic fatty liver disease: the Dionysos nutrition and liver study. Hepatology. 2005 Jul;42(1):44-52. doi: 10.1002/hep.20734.

  PMID: 15895401 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Serum Plasma Stool Urine

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Rossella Donghia, Biologyst

  IRCCS "Saverio de Bellis" - Castellana Grotte (BA) - Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rossella Donghia, Biologyst

CONTACT

+39080994652; rossella.donghia@irccsdebellis.it

Caterina Bonfiglio, statistician

CONTACT

+390804994650; catia.bonfiglio@irccsdebellis.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 17, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share