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Carotid Wall Texture as a Cardiovascular Risk Biomarker in Type 2 Diabetes Mellitus
Sponsor: Cardenal Herrera University
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.
Official title: Carotid Wall Layer Texture as a Potential Biomarker for Cardiovascular Risk Assessment in Preventive Nursing: a Study in Type 2 Diabetes Mellitus
Key Details
Gender
All
Age Range
40 Years - 69 Years
Study Type
OBSERVATIONAL
Enrollment
80
Start Date
2026-01-25
Completion Date
2026-08-02
Last Updated
2026-01-29
Healthy Volunteers
Yes
Conditions
Interventions
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%
SCORE2-Diabetes
Will also classify individuals into four risk categories: low (\<5%), moderate (5-10%), high (10-20%), and very high (\>20%).
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.
Locations (1)
Francisco Javier Molina Payá
Elche, Alicante, Spain