Screening and treatment for heart disease in patients with type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates whether a combined screening and treatment strategy for cardiovascular disease (CVD) is beneficial for patients with type 2 diabetes who do not have known CVD. It aims to determine if patients identified as high-risk through coronary artery calcium (CAC) scoring benefit from intensified treatment, while also assessing the safety of reducing treatment intensity in low-risk patients. Additionally, the study will evaluate patient-reported health outcomes and cost-effectiveness of the interventions. The approach utilizes advanced noninvasive imaging techniques to assess coronary atherosclerosis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* New or former diagnosis of Type 2 diabetes according to WHO.
* Age between 55-69 years (men) and 60-74 years (women).
* Signed declaration of consent

Exclusion Criteria:

* Previous history of CVD (previous myocardial infarction or coronary intervention (percutaneous coronary intervention or by-pass), heart failure, stroke or peripheral artery disease as documented by the patient or the patient medical record).
* Contraindications or allergies to both SGLT2 inhibitors and GLP-1 analogues.
* Signs of critical cardiac disease: \>50% stenosis of left main coronary artery (CT angiography) or left ventricular ejection fraction below 30% (echocardiography). If a CT angiography is not available, a CAC\>1000 on the non-contrast cardiac CT will be considered equal to critical cardiac disease.
* Expected life duration \< 1 year for any reason.

Where it's running

• Odense University Hospital
  Odense, Denmark Recruiting

Study contacts

• Principal investigator: Per L Poulsen, Professor — Steno Diabetes Center Aarhus, AUH, and Aarhus University
• Study coordinator: Kristian L Funck, MD PhD
• Email: klf@clin.au.dk
• Phone: +4561331588

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.