Not Yet RecruitingNot Applicable

Adipose Visceral and Epicardial Risk Evaluation

400 participantsStarted 2026-05-01

Plain-language summary

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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 clinica…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Single time point at enrollment (baseline)

Trial details

NCT IDNCT07504679

SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-03-30

View on ClinicalTrials.gov More Subclinical Atherosclerosis trials