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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.
Cardiovascular disease (CVD) is the leading cause of death worldwide and accounts for approximately 45% of all deaths in Europe. Beyond mortality, CVD has a substantial impact on patients' quality of life and represents a significant economic burden on healthcare systems. T2DM is a key cardiovascular risk factor and an important determinant of serious cardiovascular complications, as it is associated with a worse prognosis after cardiac events and almost doubles the risk of all-cause mortality.
Primary prevention of CVD is a cornerstone of nursing practice, especially in the management of chronic diseases such as T2DM, where lifestyle interventions and long-term follow-up are essential. Several tools are available for the early detection of CVD, including cardiovascular risk (CVR) prediction models and imaging techniques. SCORE2 and SCORE2-Diabetes are widely used algorithms for estimating the 10-year risk of major cardiovascular events in European adults. Imaging modalities, such as carotid ultrasound, are becoming increasingly relevant, not only as diagnostic tools but also as support resources in nurse-led clinical assessment, as they provide objective and visual biomarkers of vascular health.
Carotid ultrasound allows for the assessment of established parameters related to CVR, such as CIMT, echogenicity, echovariation, and wall texture. Intima-media thickness (IMT) is a well-recognized marker of arterial injury and cardiovascular risk, especially in people with T2DM. While echogenicity and echovariation reflect tissue composition and structural heterogeneity, they may not detect early microstructural alterations. In contrast, texture features derived from gray-level co-occurrence matrix (GLCM) analyze spatial relationships between pixels, allowing the detection of subtle arterial changes associated with cardiovascular risk. Therefore, in nursing practice, layer-specific carotid texture analysis may offer a more accurate and personalized assessment of cardiovascular risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 2 diabetes mellitus |
| ||
| Healthy Subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCORE2 | Diagnostic Test | Will classify individuals into four cardiovascular risk categories:
|
| Measure | Description | Time Frame |
|---|---|---|
| SCORE2 |
| baseline |
| SCORE2 - Diabetes | Low (<5%), moderate (5-10%), high (10-20%), and very high (>20%) | baseline |
| Energy or angular second moment (ASM) | This measures the uniformity or regularity in the distribution of image values. Higher values indicate greater uniformity in the image | baseline |
| Homogeneity or inverse difference moment (IDM) | This reflects the homogeneity of image composition, associated with pixel pairs. Homogeneous images with minimal variations produce high IDM valueS | baseline |
| Contrast (CON) | Represents the degree of local variations in grey levels within the image. The greater the variation, the greater the contrast | baseline |
| Textural correlation (TCOR) | Expresses linear dependencies between grey levels in the image. Regions with similar grey levels tend to exhibit higher values | baseline |
| Entropy (ENT) | This indicates the level of disorder within the image. Homogeneous images result in lower entropy values |
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Inclusion Criteria
Exclusion Criteria
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European population aged between 40 and 69 years without known cardiovascular disease.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SERGIO MONTERO NAVARRO, PhD | Contact | +34965426486 | 67506 | sergio.montero@uchceu.es |
| Name | Affiliation | Role |
|---|---|---|
| FRANCISCO JAVIER MOLINA PAYÁ, PhD | CEU CARDENAL HERRERA UNIVERSITY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Francisco Javier Molina Payá | Recruiting | Elche | Alicante | 03204 | Spain |
The data associated with this paper will be available in the Zenodo repository
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 20, 2026 | Jan 20, 2026 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| SCORE2-Diabetes | Diagnostic Test | Will also classify individuals into four risk categories: low (<5%), moderate (5-10%), high (10-20%), and very high (>20%). |
|
| Ultrasound Assessment | Diagnostic Test | 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. |
|
| baseline |
| Carotid intima-media thickness (CIMT) | (mm) | baseline |
| Echointensity | The mean pixel intensity within an ultrasound region of interest (related to tissue brightness/echo) | baseline |
| Echovariation | The variability or dispersion of pixel intensity within the ultrasound region of interest, corresponding to a measure of tissue heterogeneity | baseline |
| D004700 | Endocrine System Diseases |