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Non-invasive Tests for Non-alcoholic Steato-hepatitis

NCT07502755 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 828

Last updated 2026-03-31

No results posted yet for this study

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

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

Sponsors & Collaborators

  • National Research Council, Institute of Clinical Physiology, Italy

    collaborator OTHER

  • Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

    collaborator OTHER

  • Federico II University

    collaborator OTHER

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Geltrude Mingrone · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-31
Primary Completion
2027-02-28
Completion
2027-02-28

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07502755 on ClinicalTrials.gov