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Life sciences · Interventional Study
ClinicalTrials.gov · October 16, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07878325). This is a study registration, not published results. Lead sponsor: Odense University Hospital. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 375 participants (ESTIMATED). Conditions: Cardiovascular Disease, Cardiometabolic Diseases, Diabetes Type 2, Diabetes and Heart Failure, Heart Failure With Preserved Ejection Fraction (HFpEF, Diabetes Complication. Interventions: OTHER: Cardio-Metabolic Clinic. Primary outcome measures: 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. , Baseline and 12 months; Change in global mean pericoronary adipose tissue (PCAT) attenuation from baseline to 12 months compared between the intervention and usual-care groups. , Baseline and 12 months. Brief summary: 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