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.
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
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.);
Single group
Peripheral blood sampling
Other interventionCollection of blood specimens for biochemical, cellular, and molecular studies.
Association between epicardial and visceral fat thickness and low-grade inflammatory biomarkers with cardiometabolic and hepatic outcomes
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)
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This trial is not recruiting at the moment. You can still explore other options:
