NCT07502755

Non-invasive Tests for Non-alcoholic Steato-hepatitis

Non-invasive Blood Tests for the Diagnosis and Therapeutic Monitoring of Non-alcoholic Steato-hepatitis

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 828 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The main objective is to study and validate a new approach for NASH and liver fibrosis diagnosis and personalized follow-up based on monocyte biomarkers and plasma metabolites. The investigators will assess if PLIN2 and RAB14 can be used not only to identify subjects with NASH and advanced fibrosis but also for monitoring the effect of treatment alone or in combination with other metabolic parameters

Conditions

• NASH With Fibrosis
• Diabete Type 2
• Obesity

Interventions

Type	Name	Description
PROCEDURE	Administration of Deuterated water	A blood sample will be taken in the morning after an overnight fast and after consuming deuterated water (2H2O) (3 g/kg body water) the evening before the study day to achieve a plasma water enrichment of 0.3% for the measurement of DNL

Timeline

• Start date: 2024-08-31
• Primary completion: 2027-02-28
• Completion: 2027-02-28
• First posted: 2026-03-31
• Last updated: 2026-03-31

Locations

1 site across 1 country: Italy