Adipose Visceral and Epicardial Risk Evaluation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥ 18 years

Outpatients attending screening or prevention programs at Fondazione Policlinico Universitario A. Gemelli IRCCS

Ability to provide written informed consent

Additional blood collection for metabolic and inflammatory biomarker analyses

Disqualifiers

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.);

Trial design

Treatments tested in this trial

  • Peripheral blood sampling

Treatment groups

400 Participants
are divided into 1 treatment group

Locations

This trial has no locations