Adipose Visceral and Epicardial Risk Evaluation

Overview

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.

Interventions

• Other Peripheral blood sampling
  Collection of blood specimens for biochemical, cellular, and molecular studies.

Primary outcome measures

• 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07504679 · 7919

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗