Biomarkers in the Diagnosis and Prognosis of NAFLD

StatusUnknown
PhaseNot specified
Started

Record status This record was last updated October 24, 2023 (before its estimated September 22, 2025 completion). Its status may not reflect the trial's current state.

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Record History

  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Oct 2023); last known: Recruiting
  2. Minor Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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Fibrosis is considered the leading cause of liver diseases and related mortality. Specifically, hepatic fibrosis is regarded as the consequence of reparative mechanisms initiated by hepatocytes in response to chronic damage. In Western countries, the main known etiologies include hepatitis (B and C), alcoholism, and non-alcoholic steatohepatitis (NASH). In particular, obesity is a determining factor in the onset and development of NASH. Alarming statistical data indicate that over 30% of the world's population is obese, and this eating disorder is increasingly affecting young people. NASH is a chronic disease that can present different degrees of fibrosis and, as the final stage, lead to the development of liver cirrhosis. Currently, the only accurate diagnostic and assessment system for this condition is liver biopsy, as there are no accurate non-invasive clinical tests available. The aim of this project is to identify (in silico) potential biomarkers involved in the development and progression of hepatic fibrosis and validate their presence and quantity in serum or plasma samples from obese patients (at-risk population). This would avoid the need for a liver biopsy and allow "at-risk" patients to undergo a simple ambulatory blood draw. Additionally, performing elastometry of the liver would allow for comparison of radiological results with laboratory findings.
Trial Details
NCT Number NCT06098417
Lead Sponsor University of Trieste
Conditions
(from sponsor)
NAFLD, Obesity, Liver Fibrosis, Diabetes Mellitus, Type 2
Related terms Diabetes Mellitus, Type 2, Liver Cirrhosis, Non-alcoholic Fatty Liver Disease, Obesity
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov