An interventional study of Cardio-Metabolic Clinic in Diabetes Mellitus, Type 2 and Cardiovascular Diseases, sponsored by Odense University Hospital. Recruiting at 1 site in Denmark. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-07-08.
Sponsored by Odense University Hospital · Not applicable, Interventional, and Prevention
This study aims to investigate whether a Cardio-Metabolic Clinic can protect the cardiovascular health of patients with both diabetes and cardiovascular disease.
Background:
Despite improved treatment options, cardiovascular disease remains the leading cause of illness and death among patients with type 2 diabetes. It is crucial to recognize that managing diabetes involves more than just controlling blood sugar levels; preventing and treating cardiovascular disease is of significant importance. Lifestyle changes have been proven to have a substantial impact on cardiovascular health. Additionally, remarkable advancements in treatment options with cardiovascular protective effects have occurred over the past five years. Nevertheless, the traditional healthcare system primarily focuses on managing individual diseases, often leading to fragmented care for patients with type 2 diabetes. This fragmented approach often results in inadequate treatment, higher costs, and worse outcomes for cardiovascular disease. To address these challenges, our goal is to establish a Cardio-Metabolic Clinic that adopts a multidisciplinary approach to optimize diabetes management. The clinic will place special emphasis on implementing measures to protect the cardiovascular system and ensure comprehensive care for the patients. By bridging the gap between diabetes management and cardiovascular health, the aim is to enhance cardiovascular outcomes for patients with type 2 diabetes.
Organization in the Cardio-Metabolic Clinic:
The Cardio-Metabolic Clinic, structured on a cost-effective model, operates through a three-layered system centered on the patient. The innermost layer involves medical students or specialized cardio-metabolic nurses who maintain the daily contact with the patients. Patient medical history and baseline visit data are recorded in the Electronic Case-Report Form (Redcap). Upon randomization to the intervention arm, a decision-making algorithm in the Redcap-system is activated, ensuring that patients receive optimal and tailored medical treatment in accordance with the latest guidelines for diabetes management. The second layer includes a cardiologist who, in collaboration with the medical students or cardio-metabolic nurses, reviews the patients' risk profiles and algorithm-recommended treatments. If further counselling is needed for patient management, the third layer, consisting of an endocrinologist, a nephrologist and a hepatologist, will be consulted. This multidisciplinary collaboration ensures the most optimal diabetes management, especially in challenging cases.
Objectives:
The objective of the ProtecT-2-D trial is to investigate whether a comprehensive care in a Cardio-Metabolic Clinic are superior to standard treatment in reducing cardiovascular morbidity and mortality.
Hypothesis:
In patients with type 2 diabetes and cardiovascular disease, a systematic, specialized multidisciplinary approach in a Cardio-Metabolic Clinic, will result in better management of diabetes and reduced cardiovascular morbidity and mortality.
Methods:
The ProtecT-2-D study is a prospective, randomized, controlled trial conducted at the Cardiovascular Research Unit in Svendborg Hospital, Denmark. The study population consists of patients with type 2 diabetes and established cardiovascular disease, referred from general practices or seen in the outpatient clinic of Cardiology or Endocrinology at Svendborg Hospital. Sixteen hundred patients are anticipated to take part in the study. Patients are randomized in a 2:1 ratio to either receive comprehensive care at the Cardio-Metabolic Clinic or standard treatment. All patients are invited to undergo a health examination at baseline. Subsequently, patients enrolled in the Cardio-Metabolic Clinic will undergo a thorough multidisciplinary evaluation, including an optimization of lifestyle factors and medical treatment of cardiovascular risk factors based on current treatment guidelines.
After a duration of 3 years, all patients will be invited for a follow-up health examination. Furthermore, complications related to diabetes or cardiovascular disease will be assessed through registry and journal audits after 5 and 10 years.
Outcomes:
The primary outcome of the ProtecT-2-D trial is to investigate whether comprehensive care in a Cardio-Metabolic Clinic is superior to standard treatment. This will be assessed by the time to first occurrence of any of the endpoints in this composite: Death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, and hospitalization for HF.
Sample size estimation:
A reduction in the primary endpoint of 15 % is anticipated in patients assessed in the Cardio-Metabolic Clinic compared to standard treatment. With a power of 80% and an alpha value of 0.05, 1306 patients are needed, and a dropout rate of around 15-20% is anticipated; therefore, 1600 patients will have to be included in the study.
9,362 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,317 are open to participants now.
This study's planned enrollment of 1,600 is above the median of 80 across 7,528 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Odense University Hospital is the lead sponsor of 468 studies on the registry; 109 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Atherosclerotic disease defined as:
Exclusion:
Comprising specialized, multidisciplinary management of diabetes and cardiovascular disease in a Cardio-Metabolic Clinic.
Other: Cardio-Metabolic Clinic
Involving collaboration between the general practitioner, and/or the endocrinology outpatient clinic, and/or cardiology outpatient clinic.
The Cardio-Metabolic Clinic will adhere to a standardized evaluation and treatment program based on the latest treatment guidelines from the European Cardiovascular Society. The assessment will include the following points: * 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
Time to first occurrence of major adverse cardiovascular event (MACE), a composite endpoint consisting of: cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke, and hospitalisation for heart failure (HF).
Measured in days.
Time frame: From baseline to 5 years of follow-up
Time to first occurrence of MACE, a composite endpoint consisting of: CV death, non-fatal myocardial infarction, non-fatal stroke, and hospitalisation for HF.
Measured in days.
Time frame: From baseline to 10 years of follow-up
Time to occurrence of the individual component CV death
Measured in days. Including: acute myocardial infarction, venous thromboembolic event, malignant arrhythmia, cardiogenic shock, fatal stroke and aorta dissection.
Time frame: From baseline to 5 and 10 years of follow-up
Time to occurrence of the individual component AMI.
Measured in days. Including: ST-elevation myocardium infarction and non-ST-elevation myocardium infarction
Time frame: From baseline to 5 and 10 years of follow-up
Time to occurrence of the individual component non-fatal stroke.
Measured in days. Including: Thromboembolic or undetermined
Time frame: From baseline to 5 and 10 years of follow-up
Time to first occurrence of a composite heart failure endpoint consisting of: de novo HF and HF hospitalisation.
Measured in days.
Time frame: From baseline to 5 and 10 years of follow-up
Number of overall symptom burden determined by summing the occurences of CV death, non-fatal myocardial infarction, non-fatal stroke, and hospitalisation for HF.
Measured in count of events.
Time frame: From baseline to 5 and 10 years of follow-up
Change in diabetic retinopathy stage based on eye examination (fundoscopy)
Measured in ratio to baseline.
Time frame: From baseline to 3 years of follow-up
Change in estimated Glomerular Filtration Rate (eGFR)
Measured in in ratio to baseline \[mL/min/1.73 m\^2\] Creatinine-based.
Time frame: From baseline to 3 years of follow-up
Change in urinary albumin-to-creatinine ratio (UACR)
Measured in ratio to baseline.
Time frame: From baseline to 3 years of follow-up
Change in Chronic Kidney Disease (CKD) stage
Measured in ratio to baseline. Calculated by eGFR and albuminuria.
Time frame: From baseline to 3 years of follow-up
Time to first occurrence of a composite CKD endpoint consisting of a decline in eGFR [mL/min/1.73 m²] of more than 50%, onset of end-stage kidney disease (dialysis, eGFR<15, kidney transplantation) or death from renal or CV causes
Measured in count of events.
Time frame: From baseline to 3 years of follow-up
Change in fibrosis-4 (FIB-4)
Measured in ratio to baseline. FIB-4 is a biomarker assessing degree of liver fibrosis. Calculated using age, aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), and platelet count.
Time frame: From baseline to 3 years of follow-up
Change in degree of liver fibrosis in high-risk individuals assessed through a Fibro-scan
Measured in count of events.
Time frame: From baseline to 3 years of follow-up
Time to first occurrence of a composite macrovascular diabetic complications endpoint comprising new diagnosis of lower extremity arterial disease (LEAD), new/progression of foot ulcers, surgical procedures related to PAD, and coronary revascularisation
Measured in count of events. Surgical procedures in relation to PAD includes: percutaneous transluminal angioplasty, peripheral artery bypass, thrombectomy, thrombolysis, amputations. Coronary revascularisation includes: percutaneous coronary intervention (PCI), and/or coronary artery bypass graft.
Time frame: From baseline to 3 years of follow-up
Change in ankle-brachial pressure index (ABI).
Measured in ratio to baseline.
Time frame: From baseline to 3 years of follow-up
Change in protocol-driven medication
Measured in percentage (%). Protocol-driven medication includes: * Lipid lowering medication * Antihypertensive medication * Anti-thrombotic medication * Anti-diabetic medication * Nephro-protective medication
Time frame: From baseline to 3 years of follow-up
Change in symptoms as reported by patients using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Measured in score points (change in percentage \[%\])
Time frame: From baseline to 3 years of follow-up
Net cost analysis of implementing a Cardio-Metabolic Clinic
Measured in dollars \[$\]. Cost of Cardio-Metabolic Clinic minus averted costs ( including averted admissions, medical treatment, and productivity).
Time frame: From baseline to 5 and 10 years of follow-up
Change in health outcomes measured by quality-adjusted life years (QALY)
Measured in score points (change in percentage \[%\])
Time frame: From baseline to 5 and 10 years of follow-up
Cost-effectiveness ratio of implementing a Cardio-Metabolic Clinic
Measured as: Net costs/change in health outcomes \[$/QALY\]
Time frame: From baseline to 5 and 10 years of follow-up
Plan to share: No
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Odense University Hospital