Adipose Visceral and Epicardial Risk Evaluation (AVERE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Subclinical Atherosclerosis
• Intervention / Treatment: Other: Peripheral blood sampling

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients undergoing cardiometabolic evaluation; Demographic data, anthropometric measures, physical examination and information about medical history, concomitant medication and variables related to inclusion criteria are collected. Peripheral venous blood sampling for collection of biological specimens to perform biochemical, cellular, and molecular analyses aimed at assessing immuno-metabolic and inflammatory parameters.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Single time point at enrollment (baseline)

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 7919

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No