The goal of this clinical trial is to investigate the effects of a specialized Cardio-Metabolic Clinic (CMC) in people with type 2 diabetes and established cardiovascular disease. The CMC provides integrated and individualized diabetes and cardiovascular care aimed at optimizing medication, lifestyle, and management of related health conditions. Treatment recommendations are supported by a decision-support algorithm combining individual patient information with current clinical guidelines.
Echo-CT-ProtecT-2D comprises two parallel studies conducted within the same randomized study population:
Study 1 - EchoProtecT-2D focuses on cardiac function and heart failure phenotyping. The main questions are:
* Can treatment in the CMC improve heart function at rest and during physical activity compared with usual care? * Can treatment in the CMC reduce systemic inflammation and improve physical function, symptoms, and quality of life? * How common is previously unrecognized heart failure, particularly heart failure with preserved ejection fraction (HFpEF), in this high-risk population?
Study 2 - CT-ProtecT-2D focuses on coronary inflammation and atherosclerosis. The main questions are:
* Can treatment in the CMC reduce inflammation around the coronary arteries compared with usual care? * Can treatment in the CMC reduce the burden of coronary atherosclerosis compared with usual care? * Can treatment in the CMC lead to favorable changes in the composition and high-risk features of coronary atherosclerotic plaques compared with usual care?
Participants will be randomly assigned to either treatment in the CMC or usual care provided by their regular healthcare providers.
Participants will:
* Have an ultrasound examination of the heart (echocardiography) at rest and during physical activity at baseline and after 12 months * Have a CT scan of the coronary arteries at baseline and after 12 months * Provide blood and urine samples * Complete questionnaires about symptoms and quality of life * Complete a six-minute walk test to assess physical function * If assigned to the CMC, attend additional clinic visits as needed to optimize treatment
> 18 years of age
Capable of giving written informed consent.
Established diagnosis of Type 2 diabetes.
Prior stroke
Life expectancy less than 5 years for any reason.
Type 1 Diabetes Mellitus (26).
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.
Patients with a history of chronic heart failure: HFrEF, HFmrEF.
Parallel
Cardio-Metabolic Clinic
Other interventionMultifactorial management of T2D and cardiovascular disease, including comprehensive assessment of macro- and microvascular complications and individualized treatment optimization according to current clinical guidelines and recommendations. Treatment optimization is supported by an algorithm integrating individual patient data with guideline-based recommendations. The assessment will encompass the following treatment areas: * Lipid management * Blood pressure management * Antithrombotic therapy * Glycemic targets * Prevention of diabetes-related complications * Treatment of vascular disease affecting the lower extremities * Evaluation of cardioprotective drugs * Counseling on lifestyle factors, including diet, smoking, alcohol, and exercise * Guidance on vaccinations
Change in resting E/e' from baseline to 12 months follow-up, comparing the intervention and usual-care groups, with dedicated analysis of the HFpEF subgroup.
E/e' is an echocardiographic measure used to estimate left ventricular filling pressure. E/e' will be calculated as the ratio of early transmitral inflow velocity (E) to early diastolic mitral annular velocity (e'), using the average of septal and lateral e' velocities.
Change in global mean pericoronary adipose tissue (PCAT) attenuation from baseline to 12 months compared between the intervention and usual-care groups.
Coronary inflammation will be assessed by coronary computed tomography angiography (CCTA) using global mean pericoronary adipose tissue (PCAT) attenuation, expressed in Hounsfield units (HU). Changes from baseline to 12 months will be compared between the intervention and usual-care groups.
Change in E/e' during exercise from baseline to 12 months comparing the intervention and usual-care groups, with dedicated analysis of the HFpEF subgroup.
E/e' during exercise will be assessed by exercise stress echocardiography as an estimate of left ventricular filling pressure. E/e' will be calculated as the ratio of early transmitral inflow velocity (E) to early diastolic mitral annular velocity (e'), using the average of septal and lateral e' velocities. Changes from baseline to 12 months will be compared between the intervention and usual-care groups.
Change in left ventricular global longitudinal strain at rest from baseline to 12 months between the intervention and usual-care groups
Left ventricular global longitudinal strain (LV GLS) will be assessed at rest using speckle-tracking echocardiography and expressed as a percentage (%). Changes from baseline to 12 months will be compared between the intervention and usual-care groups.
Change in left ventricular global longitudinal strain during exercise from baseline to 12 months between the intervention and usual-care groups
Left ventricular global longitudinal strain (LV GLS) will be assessed during exercise using speckle-tracking echocardiography and expressed as a percentage (%). Changes from baseline to 12 months will be compared between the intervention and usual-care groups.
Change in left atrial volume index from baseline to 12 months comparing the intervention and usual-care groups
Left atrial volume index (LAVI) will be assessed by transthoracic echocardiography at rest and expressed in mL/m² as a measure of left atrial remodeling. Changes from baseline to 12 months will be compared between the intervention and usual-care groups.
Prespecified subgroup analysis on resting E/e' among participants with HFpEF at baseline
A prespecified subgroup analysis will evaluate the treatment effect on change in resting E/e' from baseline to 12 months among participants classified as having HFpEF at baseline. Effect modification according to baseline HFpEF status will additionally be assessed as prespecified in the Statistical Analysis Plan.
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