RecruitingNCT07373938

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

Carotid Wall Layer Texture as a Potential Biomarker for Cardiovascular Risk Assessment in Preventive Nursing: a Study in Type 2 Diabetes Mellitus

Sponsor

Cardenal Herrera University

Enrollment

80 participants

Start Date

Jan 25, 2026

Study Type

OBSERVATIONAL

Conditions

Type 2 Diabetes Mellitus

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.

Eligibility

Min Age: 40 YearsMax Age: 69 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether detailed ultrasound measurements of the texture of the carotid artery wall (the main artery in your neck) can help predict the risk of heart attack and stroke in people with type 2 diabetes who have not yet had a cardiovascular event. **You may be eligible if...** - You are a European adult between 40 and 69 years old - You have a confirmed diagnosis of type 2 diabetes - You have not yet been diagnosed with heart disease, stroke, or other cardiovascular conditions - Your medical records include required information such as blood pressure, cholesterol, and HbA1c **You may NOT be eligible if...** - You have a history of heart disease, stroke, or other cardiovascular events - You have type 1 diabetes - You have very advanced diabetes complications or severe kidney disease (eGFR below 30) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTSCORE2

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_TESTSCORE2-Diabetes

Will also classify individuals into four risk categories: low (\<5%), moderate (5-10%), high (10-20%), and very high (\>20%).

DIAGNOSTIC_TESTUltrasound 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

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NCT07373938

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