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

What this Trial Is About

Researchers are investigating new biomarkers for diagnosing and predicting non-alcoholic fatty liver disease (NAFLD), a condition linked to obesity and chronic liver damage that can lead to fibrosis and cirrhosis. The study focuses on identifying markers in blood samples that could replace invasive liver biopsies, improving diagnosis and monitoring for at-risk obese patients. This observational study explores how these biomarkers relate to liver fibrosis and steatosis in patients preparing for bariatric surgery. The study involves collecting blood samples and performing liver elastography, a non-invasive imaging test similar to ultrasound, before and after bariatric surgery. During surgery, small tissue samples from the liver and fat will be taken to analyze the presence and amount of selected biomarkers. Researchers will measure several proteins in plasma and tissues and compare these findings with clinical, laboratory, and imaging data to validate the biomarkers. Follow-up assessments will occur at six and twelve months after surgery to track changes. Participants will undergo clinical visits to collect medical history, physical measurements, and routine blood tests. Blood draws and liver elastography will be performed before surgery and at follow-up times. Tissue biopsies during surgery will help confirm liver damage stages. The main outcome is measuring soluble biomarkers of liver fibrosis at baseline, with secondary outcomes including follow-up measurements and correlation analyses with imaging and biopsy results. The study aims to improve non-invasive diagnosis and monitoring of NAFLD over about one year post-surgery.

Biomarkers in the Diagnosis and Prognosis of NAFLD