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

NCT07373938 | Recruiting

• 1 other identifier: CEEI24/547
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

ultrasound; textural analysis; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (10)

• 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%

  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

  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

Study Arms (2)

Type 2 diabetes mellitus

Diagnostic Test: SCORE2-Diabetes; Diagnostic Test: Ultrasound Assessment

Healthy Subjects

Diagnostic Test: SCORE2; Diagnostic Test: Ultrasound Assessment

Interventions

SCORE2-Diabetes DIAGNOSTIC_TEST

Will also classify individuals into four risk categories: low (\<5%), moderate (5-10%), high (10-20%), and very high (\>20%).

Type 2 diabetes mellitus

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.

Healthy Subjects; Type 2 diabetes mellitus

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%

Healthy Subjects

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cardenal Herrera University: lead

Study Sites (1)

Francisco Javier Molina Payá

Elche, Alicante, 03204, Spain

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• FRANCISCO JAVIER MOLINA PAYÁ, PhD

  CEU CARDENAL HERRERA UNIVERSITY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SERGIO MONTERO NAVARRO, PhD

CONTACT

+34965426486; sergio.montero@uchceu.es

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 28, 2026
• Study Start: January 25, 2026
• Primary Completion: January 28, 2026
• Study Completion (Estimated): August 2, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

ES (1)