Evaluating Atherosclerotic Disease Progression in Patients With Diabetes Mellitus

NCT ID: NCT07237685

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-06

Study Completion Date

2036-10-01

Brief Summary

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People with type 2 diabetes have a much higher risk of heart disease. One common problem is when the blood vessels that supply the heart become narrowed or blocked by fatty deposits, called plaque. This makes it harder for blood to reach the heart and can lead to serious problems such as chest pain, heart attacks, or even death.

This study will follow people with type 2 diabetes who have already had a special heart scan called a coronary CT angiography. This scan takes detailed pictures of the heart's blood vessels.

The goal is to understand how heart disease changes over time in people with type 2 diabetes, by looking at repeat scans and other health information. By learning more about how plaque builds up or gets worse, researchers hope to find better ways to identify which patients are most at risk for future heart problems.

Detailed Description

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Conditions

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Type 2 Diabetes Coronary Artery Disease (CAD) Atherosclerosis Cardiovascular Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age over 18 years
* Previous completion of CCTA scan for CAD assessment
* Diagnosed with Type 2 Diabetes and currently receiving glucose lowering treatment
* Sufficient image quality of the CCTA scan (at least 2/3 vessels of sufficient quality for assessment).

Exclusion Criteria

* Inability to provide written informed consent
* Presence of an unstable condition
* Ingeligibility for CCTA acquisition due to severe renal dysfunction (eGFR ≤ 30 mL/min/1.73m²) or known hypersensitivity or contraindication to CT contrast agents
* Any other treatment or clinically relevant condition that could interfere with the conduct or interpretation of the study in the opinion of the investigator
* inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study
* Baseline (routine care) CCTA performed \< 2 years or \> 5 years before inclusion
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Horizon Innovative Health Initiative

UNKNOWN

Sponsor Role collaborator

Novo Nordisk A/S

INDUSTRY

Sponsor Role collaborator

INSTITUTO DE INVESTIGACION BIOMEDICA DE SALAMANCA (IBSAL)

UNKNOWN

Sponsor Role collaborator

Cardiology Centers of the Netherlands

UNKNOWN

Sponsor Role collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role lead

Responsible Party

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M.M. Winter

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Amsterdam University Medical Centers

Amsterdam, , Netherlands

Site Status NOT_YET_RECRUITING

Cardiology Centers of the Netherlands

Amsterdam, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Willem R van de Vijver, MD

Role: CONTACT

+31205662402

Facility Contacts

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Willem R van de Vijver

Role: primary

+3120-5662402

Willem R van de Vijver, MD

Role: primary

+3120-5662402

Other Identifiers

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NL86138.018.24

Identifier Type: -

Identifier Source: org_study_id

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