Non-invasive Tests for Non-alcoholic Steato-hepatitis

N/AActive Not RecruitingNCT07502755

Fondazione Policlinico Universitario Agostino Gemelli IRCCS828 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

828

Conditions

NASH With Fibrosis Diabete Type 2 Obesity

Interventions

Administration of Deuterated waterPROCEDURE

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

Eligibility

Sex: ALLMin age: 25 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Policlinico Universitario Agostino Gemelli IRCCS: Subjects with NASH documented by liver biopsy or fibroscan and no evidence of another form of liver disease with a BMI ≥ 30 and ≤40 kg/m2. Age 25-65 years. * Coorte Azienda Ospedaliera Mater Domini: subjects with NASH documented by liver fibroscan aged \>40 years with one or more cardiovascular risk factors,including overweight/obesity, elevated blood pressure, dyslipidemia, and dysglycemia * Azienda Ospedaliero-Universitaria Policlinico Federico II: Subjects with NASH documented by fibroscan and no evidence of another form of liver disease. Age 25-65 years. Exclusion Criteria: * All units: Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous 6 months; Liver cirrhosis; End stage renal failure; Participation in any other concurrent therapeutic clinical trial; Any other life-threatening, non-cardiac disease; Pregnancy; Inability to give informed consent; Substantial alcohol consumption (\>20 g/day for women or \>30 g/day for men); Wilson's disease; Lipodystrophy; Parenteral nutrition; Abetalipoproteinemia; Interfering medications (e.g., amiodarone, methotrexate, tamoxifen, corticosteroids).

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Outcomes

Primary Outcomes

Identification of NASH and Advanced Fibrosis, using PLIN2 and RAB14, in 288 patients undergoing bariatric surgery

PLIN2 and RAB14 will be assessed by flow cytometry in monocytes stored at -80°C from all patients who participated in the BRAVES RCT (288 Subjects). PLIN2 and RAB14 median fluorescent intensity will be used to identify subjects with NASH (NAS \>=4) and advanced fibrosis (stage\>=2).

Time frame: 18 months

Secondary Outcomes

Comparison of PLIN2 and RAB14 with non-invasive test for the detection of NASH with significant fibrosis in the CATAMERIS cohort (500 subjects).

500 Subjects from the CATAMERIS cohort will undergo the following analysis: 1. Transient elastography 2. Blood sampling for the evaluation of non-invasive score (FIB4, APRI and FNI) 3. Monocyte isolation for PLIN2 and RAB14 assessment by flow cytometry 4. Plasma sample collection for metabolomic and lipidomic analysis. PLIN2 and RAB14 accuracy will be compared to Transient elastography, FIB4, APRI and FNI for the dectection of NASH with significant fibrosis

Time frame: 18 months

Data from ClinicalTrials.gov

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