Carotid Wall Texture as a Cardiovascular Risk Biomarker in Type 2 Diabetes Mellitus
Recruiting · NCT07373938 · Observational (researchers observe without assigning treatment) · Lead sponsor: Cardenal Herrera University
View the official record on ClinicalTrials.gov →Interventions studied
SCORE2SCORE2-DiabetesUltrasound Assessment
What this trial is about
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.
Who can take part
Age range
40 Years to 69 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
1 location listed.
- Francisco Javier Molina Payá - Elche, Alicante, Spain