Identification of New Biomarkers in the Diagnosis and Prognosis of Non-alcoholic Fatty Liver Disease and Correlation With Ultrasound and Elastographic Findings

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• BMI\> 35 Eligible for bariatric surgery according to the current international guidelines (IFSO guidelines)

Locations
Other Locations
Italy
Silvia Palmisano
RECRUITING
Trieste
Contact Information
Primary
Silvia Palmisano, MD
spalmisano@units.it
0403994152
Time Frame
Start Date: 2015-09-22
Estimated Completion Date: 2026-09-22
Participants
Target number of participants: 500
Sponsors
Leads: University of Trieste

This content was sourced from clinicaltrials.gov

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