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NCT Number: NCT07504679

Adipose Visceral and Epicardial Risk Evaluation

The goal of this procedure-based interventional study without drugs or devices is to investigate the molecular mechanisms underlying metabolically unfavorable obesity and related clinical phenotypes, in order to identify non-invasive biomarkers capable of early prediction of metabolic syndrome, type 2 diabetes mellitus, MASLD, and cardiovascular disease in adult participants without known cardiovascular or liver disease.

The main questions it aims to answer are:

* What is the association between epicardial and visceral fat thickness and plasma levels of low-grade inflammatory biomarkers? * How do these parameters relate to the presence of metabolic syndrome, type 2 diabetes mellitus, MASLD, and subclinical atherosclerosis?

Participants will:

* Undergo a comprehensive clinical evaluation, including demographic, anthropometric, and medical history data; * Complete non-invasive diagnostic assessments, including 12-lead electrocardiogram, transthoracic echocardiography, liver elastography (FibroScan), and carotid Doppler ultrasound; * Provide peripheral venous blood samples for biochemical, cellular, and molecular analyses.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age ≥ 18 years
  • Outpatients attending screening or prevention programs at Fondazione Policlinico Universitario A. Gemelli IRCCS
  • Ability to provide written informed consent
  • Willingness to undergo:
  • Additional blood collection for metabolic and inflammatory biomarker analyses
  • Liver elastography (FibroScan)

Exclusion criteria

  • Documented history of atherosclerotic cardiovascular disease, including myocardial infarction, angina pectoris, coronary angioplasty, coronary artery bypass grafting, peripheral artery disease, lower limb revascularization procedures, ischemic stroke, hemodynamically significant carotid stenosis, carotid endarterectomy or angioplasty, or aortopathy;
  • Known chronic liver disease of other etiology (e.g., viral hepatitis, autoimmune liver disease, hemochromatosis, alcoholic liver disease);
  • Significant alcohol consumption (>30 g/day for men, >20 g/day for women);
  • Chronic systemic inflammatory diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriasis, inflammatory bowel disease, spondyloarthritis, mixed connective tissue disease, etc.);
  • Active chronic infections, including HIV, active hepatitis B or C, untreated latent tuberculosis, or any other diagnosed chronic infection;
  • Active or past malignancy within the last 5 years;
  • Current treatment with systemic anti-inflammatory drugs, immunosuppressants, or corticosteroids at pharmacological doses;
  • Current pregnancy or breastfeeding;
  • Any clinical or psychiatric condition that, in the investigator's judgment, could compromise participation or the validity of collected data.

Treatment and study plan

Peripheral blood sampling

Other

Collection of blood specimens for biochemical, cellular, and molecular studies.

Primary outcomes

  1. Association between epicardial and visceral fat thickness and low-grade inflammatory biomarkers with cardiometabolic and hepatic outcomes

    Time frame: Single time point at enrollment (baseline)

    Evaluation of the relationship between epicardial and visceral adipose tissue thickness and plasma levels of low-grade inflammatory biomarkers (hs-CRP, IL-6, TNF-α) with the presence of:

    • Subclinical atherosclerotic disease;
    • Metabolic syndrome
    • Type 2 diabetes mellitus
    • Metabolic dysfunction-associated steatotic liver disease (MASLD)

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: AVERE

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 1, 2026
Registry last updated
Apr 1, 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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