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

NCT07373938 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2026-01-29

No results posted yet for this study

Summary

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.

Conditions

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.

Sponsors & Collaborators

  • Cardenal Herrera University

    lead OTHER

Principal Investigators

  • FRANCISCO JAVIER MOLINA PAYÁ, PhD · CEU CARDENAL HERRERA UNIVERSITY

Eligibility

Min Age
40 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-25
Primary Completion
2026-01-28
Completion
2026-08-02

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07373938 on ClinicalTrials.gov