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Active, Not Recruiting

NCT Number: NCT07502755

Non-invasive Tests for Non-alcoholic Steato-hepatitis

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

NASH With Fibrosis Body Weight Diabete Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Primary outcomes

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

    Time frame: 18 months

    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).

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).

    Time frame: 18 months

    500 Subjects from the CATAMERIS cohort will undergo the following analysis:

    • Transient elastography
    • Blood sampling for the evaluation of non-invasive score (FIB4, APRI and FNI)
    • Monocyte isolation for PLIN2 and RAB14 assessment by flow cytometry
    • 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

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.

    Time frame: 18 months

    40 subjects with NAFLD with or without fibrosis, assessed with fibroscan, will be asked to drink 3 mg/kg of deuterated water the evening before the study.

    The following analysis will be performed after the administration of deuterated water :

    PLIN2 and RAB14 will be assessed by flow cytometry in monocytes Metabolomic and lipidomic analysis will be performed in plasma samples

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Collaborators

  • Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
  • Federico II University
  • National Research Council, Institute of Clinical Physiology, Italy

Registry information

Official study title

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

Acronym: TEIRESEAS

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 31, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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