Carotid ultrasound wall texture to identify cardiovascular risk in Type 2 diabetes
Official title: Carotid Wall Layer Texture as a Potential Biomarker for Cardiovascular Risk Assessment in Preventive Nursing: a Study in Type 2 Diabetes Mellitus
Run by Cardenal Herrera University · NCT07373938 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 40 Years to 69 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Cardenal Herrera University Academic / other |
| Locations | 1 site (Elche, Alicante) |
| Status | Recruiting |
| Started | January 25, 2026 |
| Main results expected | January 28, 2026 |
| Study ends | March 2, 2027 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT07373938 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Ocular Changes in People Using Tirzepatide or Semaglutide
This study checks whether eye structure and blood vessels change in adults with obesity who are taking semaglutide or tirzepatide as part of routine care.
-
Acupuncture plus vitamin B12 for diabetic heart nerve damage
This study tests whether adding acupuncture to standard care and vitamin B12 can help adults with type 2 diabetes who have damaged the nerves that control the heart.
-
Clinical decision support to help consider SGLT2 inhibitors after AKI in type 2 diabetes
This pilot test checks if a CDS message given to clinicians can help decide whether to consider SGLT2 inhibitors for adults with type 2 diabetes who recently had acute kidney injury.
-
Body composition changes after starting GLP-1 therapies in adults with obesity or type 2 diabetes
This study will follow adults with obesity and/or type 2 diabetes who are starting or adjusting a GLP-1 receptor agonist to see how their muscle and fat change over about a year.
-
Single-dose PK study of HRS-4729 in adults with and without kidney impairment
This study tests a single dose of HRS-4729 to see how the body handles it in adults with various levels of kidney function compared with healthy adults.
-
Once-daily ASC30 to See if it helps adults with obesity or overweight and Type 2 diabetes
This study tests three daily doses of ASC30 against placebo in adults who are overweight or obese and have Type 2 diabetes to see if it helps with weight loss and safety over time.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.