Cardio-Metabolic Clinic care for adults with type 2 diabetes and cardiovascular disease

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

The study uses a randomized design to compare an integrated Cardio-Metabolic Clinic approach with standard care in adults with type 2 diabetes and established cardiovascular disease. The clinic combines personalized diabetes and cardiovascular treatment guided by a decision-support algorithm that aligns with current guidelines. The two parallel components examine heart function, inflammation, physical performance, symptoms, and quality of life, while also screening for previously unrecognized heart failure. Major therapeutic advances in diabetes and cardiovascular care inform the intervention, with assessments focused on HFpEF risk and overall cardiometabolic outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. \> 18 years of age
2. Capable of giving written informed consent.
3. Established diagnosis of Type 2 diabetes.
4. Established heart or vascular disease, defined as either:

4a. Atherosclerotic disease defined as one of the following: I. Prior acute coronary syndrome, defined according to ESC guidelines.

II. Chronic coronary syndrome defined according to ESC guidelines:

a) Angina pectoris AND b) Signs of coronary atherosclerosis assessed with either coronary CT angiography (CTA) or myocardial-scintigraphy (MPI) or coronary angiography (CAG) AND c) treatment with statins and/or acetylsalicylic acid.

III. Ischemic heart disease defined by one of the following criteria: a) Myocardial-scintigraphy: \>10% reversibility OR b) Coronary CT angiography: Coronary Artery Calcium-score \>100.

IV. Non coronary vascular disease defined as:

1. Prior stroke
2. Peripheral arterial disease (PAD) PAD is defined as: Claudication intermittence AND pathological ankle brachial index (ABI) AND/OR vascular PAD surgery AND/OR ischemic amputation 4b. Atrial fibrillation and/or flutter, including paroxysmal, persistent and chronic disease defined according to ESC guidelines.

   4c. Clinically significant valvular heart disease (which requires control in outpatient clinic of cardiology), such as: Aortic valve stenosis, mitral valve insufficiency, and patients with aortic dilatation.

   4d. Hypertension treated with a minimum of three antihypertensive drugs. 4e. Heart failure with preserved ejection fraction (HFpEF)

   Exclusion Criteria:
   1. Life expectancy less than 5 years for any reason.
   2. Type 1 Diabetes Mellitus (26).
   3. Participation in another clinical trial with an investigational product or device that could interfere with the primary and/or secondary endpoints of this or the ProtecT-2D parent study.
   4. Patients with a history of chronic heart failure: HFrEF, HFmrEF.

Where it's running

• Cardiovascular Research Unit at Odense University Hospital, Svendborg, Denmark.
  Svendborg, Denmark Recruiting

Study contacts

• Study coordinator: Aiyla Mira-Kena Lorenzen, M.D
• Email: Aiyla.mira-kena.lorenzen2@rsyd.dk
• Phone: +45 28 77 99 97

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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.