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NCT Number: NCT07373938

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Francisco Javier Molina Payá

Elche, Alicante, 03204, Spain

Location status: Recruiting

Location contact

SERGIO MONTERO NAVARRO

CONTACT

[email protected]

+34 96 542 64 86 ext. 67509

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

SCORE2

Diagnostic Test

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

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.

Primary outcomes

  1. SCORE2

    Time frame: baseline

    • 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%

  2. SCORE2 - Diabetes

    Time frame: baseline

    Low (<5%), moderate (5-10%), high (10-20%), and very high (>20%)

  3. Energy or angular second moment (ASM)

    Time frame: baseline

    This measures the uniformity or regularity in the distribution of image values. Higher values indicate greater uniformity in the image

  4. Homogeneity or inverse difference moment (IDM)

    Time frame: baseline

    This reflects the homogeneity of image composition, associated with pixel pairs. Homogeneous images with minimal variations produce high IDM valueS

  5. Contrast (CON)

    Time frame: baseline

    Represents the degree of local variations in grey levels within the image. The greater the variation, the greater the contrast

  6. Textural correlation (TCOR)

    Time frame: baseline

    Expresses linear dependencies between grey levels in the image. Regions with similar grey levels tend to exhibit higher values

  7. Entropy (ENT)

    Time frame: baseline

    This indicates the level of disorder within the image. Homogeneous images result in lower entropy values

  8. Carotid intima-media thickness (CIMT)

    Time frame: baseline

    (mm)

  9. Echointensity

    Time frame: baseline

    The mean pixel intensity within an ultrasound region of interest (related to tissue brightness/echo)

  10. Echovariation

    Time frame: baseline

    The variability or dispersion of pixel intensity within the ultrasound region of interest, corresponding to a measure of tissue heterogeneity

Study contacts

Contact information is provided by the study sponsor or research team.

SERGIO MONTERO NAVARRO, PhD

CONTACT

[email protected]

+34965426486 ext. 67506

Sponsors and collaborators

Lead sponsor

Cardenal Herrera University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 28, 2026
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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