NCT06098417 Biomarkers in the Diagnosis and Prognosis of NAFLD
| NCT ID | NCT06098417 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Trieste |
| Condition | NAFLD |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2015-09-22 |
| Primary Completion | 2025-09-22 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2015-09-22 with a primary completion date of 2025-09-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: BMI\> 35 Eligible for bariatric surgery according to the current international guidelines (IFSO guidelines) Exclusion Criteria: * Patients affected by active liver viral infection * Patient alcohol or drug addicted * Incompetent patients
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06098417 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying NAFLD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06098417 currently recruiting?
Yes, NCT06098417 is actively recruiting participants. Contact the research team at spalmisano@units.it for enrollment information.
Where is the NCT06098417 trial being conducted?
This trial is being conducted at Trieste, Italy.
Who is sponsoring the NCT06098417 clinical trial?
NCT06098417 is sponsored by University of Trieste. The trial plans to enroll 500 participants.