Type 2 Diabetes MellitusNCT07373938
Carotid Wall Texture as a Cardiovascular Risk Biomarker in Type 2 Diabetes Mellitus
An observational study of Type 2 Diabetes Mellitus, run by Cardenal Herrera University at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- SCORE2, SCORE2-Diabetes and Ultrasound Assessment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 25 Jan 2026to 2 Mar 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: European population aged between 40 and 69 years without known cardiovascular disease.
Who may be able to join
- 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)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Francisco Javier Molina Payá
Elche, Alicante, 03204
SERGIO MONTERO NAVARRO, +34 96 542 64 86 ext. 67509, sergio.montero@uchceu.es
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- SCORE2, SCORE2-Diabetes, Ultrasound Assessment
- Keywords
- ultrasound, textural analysis, Type 2 Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCORE2Diagnostic 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-DiabetesDiagnostic test
Will also classify individuals into four risk categories: low (<5%), moderate (5-10%), high (10-20%), and very high (>20%).
Ultrasound AssessmentDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetes mellitus | Not described Receives: Diagnostic Test: SCORE2-Diabetes; Diagnostic Test: Ultrasound Assessment | |
| Healthy Subjects | Not described Receives: Diagnostic Test: SCORE2; Diagnostic Test: Ultrasound Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCORE2
- 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%
Measured: baseline
SCORE2 - Diabetes
Low (<5%), moderate (5-10%), high (10-20%), and very high (>20%)
Measured: 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
Measured: 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
Measured: baseline
Contrast (CON)
Represents the degree of local variations in grey levels within the image. The greater the variation, the greater the contrast
Measured: baseline
Textural correlation (TCOR)
Expresses linear dependencies between grey levels in the image. Regions with similar grey levels tend to exhibit higher values
Measured: baseline
Entropy (ENT)
This indicates the level of disorder within the image. Homogeneous images result in lower entropy values
Measured: baseline
Carotid intima-media thickness (CIMT)
(mm)
Measured: baseline
Echointensity
The mean pixel intensity within an ultrasound region of interest (related to tissue brightness/echo)
Measured: baseline
Echovariation
The variability or dispersion of pixel intensity within the ultrasound region of interest, corresponding to a measure of tissue heterogeneity
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start25 Jan 2026
- Primary completion28 Jan 2026
- Study completion2 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SERGIO MONTERO NAVARRO, Cardenal Herrera University
- Investigators
- FRANCISCO JAVIER MOLINA PAYÁ, PhD, Principal investigator, CEU CARDENAL HERRERA UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373938
- Sponsor's protocol ID
- CEEI24/547
- Status last verified
- Oct 2026
- First submitted
- 20 Jan 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data associated with this paper will be available in the Zenodo repository