Health TrialsbyHealthPanel

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

ConditionType 2 Diabetes Mellitus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-69
SponsorCardenal Herrera University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

European adults.

Age between 40 and 69 years.

Confirmed diagnosis of type 2 diabetes mellitus.

No established cardiovascular disease.

Disqualifiers

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).

Trial population

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

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • 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%

  • SCORE2-Diabetes

    Diagnostic test

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

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Type 2 diabetes mellitus2 interventions
Group B: Healthy Subjects2 interventions

Trial outcomes

Primary outcomes

1

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%

Time frame
baseline
2

SCORE2 - Diabetes

Low (\<5%), moderate (5-10%), high (10-20%), and very high (\>20%)

Time frame
baseline
3

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

Time frame
baseline
4

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

Time frame
baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cardenal Herrera University

Lead sponsor

Source ClinicalTrials.gov
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