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Recruiting NCT07373938

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

Trial Parameters

Condition Type 2 Diabetes Mellitus
Sponsor Cardenal Herrera University
Study Type OBSERVATIONAL
Phase N/A
Enrollment 80
Sex ALL
Min Age 40 Years
Max Age 69 Years
Start Date 2026-01-25
Completion 2026-01-28
Interventions
SCORE2SCORE2-DiabetesUltrasound Assessment

Brief 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 Criteria

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).

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