Non-invasive Tests for Non-alcoholic Steato-hepatitis

NCT07502755 | Active Not Recruiting

• 1 other identifier: PNRR-MCNT2-2023-12377036
• Study Type: interventional
• Target: 828
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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).

  18 months

Secondary Outcomes (1)

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

  18 months

Other Outcomes (1)

• Understanding the mechanisms underlying the formation, regulation, and metabolism of lipid droplets in the pathogenesis of NAFLD in 40 subjects with NAFLD with or without fibrosis.

  18 months

Study Arms (1)

Deuterated Water

EXPERIMENTAL

Subjects, enrolled by Operative Federico II University, will be asked to drink the evening before the study 3 mg/kg of deuterated water (2H2O). A blood sample will be taken the morning after an overnight fast and after consuming 2H2O.

Procedure: Administration of Deuterated water

Interventions

Administration of Deuterated water PROCEDURE

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

Deuterated Water

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• National Research Council, Institute of Clinical Physiology, Italy: collaborator
• Azienda Ospedaliera Universitaria Mater Domini, Catanzaro: collaborator
• Federico II University: collaborator

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Geltrude Mingrone

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: March 31, 2026
• Study Start: August 31, 2024
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: March 31, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)