Carotid ultrasound wall texture to identify cardiovascular risk in Type 2 diabetes
Carotid Wall Layer Texture as a Potential Biomarker for Cardiovascular Risk Assessment in Preventive Nursing: a Study in Type 2 Diabetes Mellitus
This project will test whether carotid ultrasound measurements, including intima-media thickness and layer-specific wall texture, can help predict 10-year heart risk in adults aged 40–69 with Type 2 diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 40 Years to 69 Years |
| Sex | All |
| Sponsor | Cardenal Herrera University Academic / other |
| Locations | 1 site (Elche, Alicante) |
| Trial ID | NCT07373938 on ClinicalTrials.gov |
What this trial studies
This observational study compares carotid intima-media thickness (CIMT) and layer-specific ultrasound texture features between adults with Type 2 diabetes and normoglycemic controls. Participants will have carotid ultrasound imaging plus collection of clinical and metabolic variables used to calculate SCORE2 and SCORE2‑Diabetes 10-year risk scores. The analysis will include echogenicity, echovariation, and texture metrics alongside CIMT to see how well these ultrasound biomarkers distinguish low- versus high-risk individuals. Results will show whether wall texture metrics add information beyond established clinical risk factors for earlier detection of vascular injury in diabetes.
Who should consider this trial
Good fit: European adults aged 40–69 with confirmed Type 2 diabetes, no prior cardiovascular disease, and available clinical/metabolic data (age, sex, systolic blood pressure, non‑HDL cholesterol, smoking status, diabetes duration, HbA1c, and organ damage markers) are ideal candidates.
Not a fit: People with prior clinical cardiovascular disease, Type 1 diabetes, established severe target organ damage, or advanced chronic kidney disease (eGFR <30 mL/min/1.73 m²) are excluded and unlikely to benefit from this study's findings.
Why it matters
Potential benefit: If successful, this approach could identify people with diabetes at higher cardiovascular risk earlier, allowing more targeted prevention and monitoring.
How similar studies have performed: Traditional CIMT and echogenicity measures have been linked to cardiovascular risk, while layer-specific texture analysis is a newer, promising technique with limited validation to date.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Elche, Alicante
- Francisco Javier Molina Payá — Elche, Alicante, Spain (Recruiting)
Study contacts
- Principal investigator: FRANCISCO JAVIER MOLINA PAYÁ, PhD — Ceu Cardenal Herrera University
- Study coordinator: SERGIO MONTERO NAVARRO, PhD
- Email: sergio.montero@uchceu.es
- Phone: +34965426486
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.