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

January 28, 2026 updated by: SERGIO MONTERO NAVARRO, Cardenal Herrera University

Carotid Wall Layer Texture as a Potential Biomarker for Cardiovascular Risk Assessment in Preventive Nursing: a Study 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Alicante
      • Elche, Alicante, Spain, 03204
        • Recruiting
        • Francisco Javier Molina Payá
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

European population aged between 40 and 69 years without known cardiovascular disease.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy Subjects
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.
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%
Type 2 diabetes mellitus
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.
Diagnostic test: SCORE2-Diabetes
Will also classify individuals into four risk categories: low (<5%), moderate (5-10%), high (10-20%), and very high (>20%).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%
baseline
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
baseline
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
baseline
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
baseline
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
baseline
Entropy (ENT)
Time Frame: baseline
This indicates the level of disorder within the image. Homogeneous images result in lower entropy values
baseline
SCORE2 - Diabetes
Time Frame: baseline
Low (<5%), moderate (5-10%), high (10-20%), and very high (>20%)
baseline
Carotid intima-media thickness (CIMT)
Time Frame: baseline
(mm)
baseline
Echointensity
Time Frame: baseline
The mean pixel intensity within an ultrasound region of interest (related to tissue brightness/echo)
baseline
Echovariation
Time Frame: baseline
The variability or dispersion of pixel intensity within the ultrasound region of interest, corresponding to a measure of tissue heterogeneity
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardenal Herrera University

Investigators

  • Principal Investigator: FRANCISCO JAVIER MOLINA PAYÁ, PhD, CEU Cardenal Herrera University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2026

Primary Completion (Actual)

January 28, 2026

Study Completion (Estimated)

August 2, 2026

Study Registration Dates

First Submitted

January 20, 2026

First Submitted That Met QC Criteria

January 20, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEEI24/547

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data associated with this paper will be available in the Zenodo repository

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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