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Carotid Wall Texture as a Cardiovascular Risk Biomarker in Type 2 Diabetes Mellitus

This study aims to compare carotid intima-media thickness (CIMT) and layer-specific texture characteristics of the carotid wall between individuals with Type 2 diabetes mellitus (T2DM) and normoglycemic controls, to assess the impact of T2DM on these ultrasound variables and evaluate their ability to discriminate between low and high cardiovascular risk at 10 years.

ClinicalTrials.gov IDNCT07373938

PhaseNot Applicable

Enrollment80

SponsorCardenal Herrera University

Age40 Years – 69 Years

SexALL

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Conditions studied

Type 2 Diabetes Mellitus

About this study

Interventions

Diagnostic Test: SCORE2 — Will classify individuals into four cardiovascular risk categories: * For participants aged 50-69 years: * Low-to-moderate risk: \<5% * High risk: ≥5% to \<10% * Very high risk: ≥10% * For participants aged 40-49 years: * Low-to-moderate risk: \<2.5% * High risk: ≥2.5% to \<7.5% * Very high risk: ≥7.5%
Diagnostic Test: SCORE2-Diabetes — Will also classify individuals into four risk categories: low (\<5%), moderate (5-10%), high (10-20%), and very high (\>20%).
Diagnostic Test: Ultrasound Assessment — Three bilateral longitudinal scans of the common carotid artery will be obtained for carotid intima-media thickness (CIMT) measurement and stratification of carotid wall layers for subsequent texture analysis. Additionally, a bilateral video recording of the same imaging plane containing a minimum of five cardiac cycles will be acquired. One end-diastolic frame per video-corresponding to the relaxed arterial wall-will be selected to standardize image acquisition and CIMT measurement.

Primary outcomes

SCORE2 (baseline)
SCORE2 - Diabetes (baseline)
Energy or angular second moment (ASM) (baseline)
Homogeneity or inverse difference moment (IDM) (baseline)
Contrast (CON) (baseline)
Textural correlation (TCOR) (baseline)
Entropy (ENT) (baseline)
Carotid intima-media thickness (CIMT) (baseline)

Eligibility information

Inclusion Criteria * European adults. * Age between 40 and 69 years. * Confirmed diagnosis of type 2 diabetes mellitus. * No established cardiovascular disease. * Availability of the required clinical and metabolic variables: Age; Sex; Systolic blood pressure; Non-high-density lipoprotein (non-HDL) cholesterol; Smoking status; Duration of diabetes; Glycated hemoglobin (HbA1c); Presence or absence of diabetes-related target organ damage (e.g., albuminuria, retinopathy) Exclusion Criteria * History of clinical cardiovascular disease (secondary prevention). * Type 1 diabetes mellitus. * Patients with established severe target organ damage or conditions that automatically classify them as very high cardiovascular risk according to ESC guidelines. * Advanced chronic kidney disease (estimated glomerular filtration rate \<30 mL/min/1.73 m²).

Study locations

Francisco Javier Molina Payá, Elche, Alicante 03204 Spain

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-20.