Actively Recruiting
Carotid Wall Layer Texture as a Potential Biomarker for Cardiovascular Risk Assessment in Preventive Nursing in Type 2 Diabetes Mellitus
Led by Cardenal Herrera University · Updated on 2026-01-29
80
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how carotid artery wall thickness and texture differ between people with Type 2 diabetes mellitus (T2DM) and those without diabetes. The study aims to understand how T2DM affects these ultrasound measurements and to evaluate their ability to predict cardiovascular risk over 10 years. Since cardiovascular disease is a leading cause of death and is worsened by T2DM, early detection tools are important for prevention and management. Participants will undergo carotid ultrasound scans to measure intima-media thickness (CIMT) and layer-specific texture features of the carotid artery wall. The study uses imaging techniques along with cardiovascular risk scores such as SCORE2 and SCORE2-Diabetes, which categorize risk levels based on age and clinical factors. Multiple bilateral scans and video recordings will be taken to assess ultrasound variables related to vascular health. During the study, participants will provide clinical and metabolic data including blood pressure, cholesterol, smoking status, and diabetes-related factors. Ultrasound images will be analyzed for thickness and texture features at baseline to assess cardiovascular risk. The study will monitor these measures to compare their ability to distinguish between low and high cardiovascular risk groups. Participation involves clinical assessments and imaging, with the primary outcome focused on cardiovascular risk classification and ultrasound parameters.
CONDITIONS
Brief Title
Carotid Wall Texture as a Cardiovascular Risk Biomarker in Type 2 Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- European adults
- Age between 40 and 69 years
- Confirmed diagnosis of type 2 diabetes mellitus
- No established cardiovascular disease
- Availability of clinical and metabolic data including age, sex, blood pressure, cholesterol, smoking status, diabetes duration, HbA1c, and presence or absence of diabetes-related organ damage
You will not qualify if you...
- History of clinical cardiovascular disease
- Type 1 diabetes mellitus
- Severe target organ damage or conditions causing very high cardiovascular risk
- Advanced chronic kidney disease with estimated glomerular filtration rate below 30 mL/min/1.73 m²
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo cardiovascular risk classification using SCORE2 and SCORE2-Diabetes algorithms, along with carotid ultrasound imaging to assess carotid intima-media thickness and wall texture for cardiovascular risk assessment.
1 visit (in-person)
Duration - Up to approximately 2 years
Participants are observed over time to monitor cardiovascular risk indicators without active intervention.
Visit schedule not specified
Trial Site Locations
Total: 1 location
1
Francisco Javier Molina Payá
Elche, Alicante, Spain, 03204
Actively Recruiting
Research Team
S
SERGIO MONTERO NAVARRO, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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