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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

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). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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).

Treatments Being Tested

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.

Locations (1)

Francisco Javier Molina Payá
Elche, Alicante, Spain