Diabetes Mellitus, Type 2ProtecT-2-DNCT06203860
The Cardio-Metabolic Clinic
A study testing Cardio-Metabolic Clinic in people with Diabetes Mellitus, Type 2 and Cardiovascular Diseases, run by Odense University Hospital at 1 site in Denmark.
Trial summary
This study aims to investigate whether a Cardio-Metabolic Clinic can protect the cardiovascular health of patients with both diabetes and cardiovascular disease. At the Cardio-Metabolic Clinic, patients will receive a specialized and comprehensive care. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
- What is being tested?
- Cardio-Metabolic Clinic
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2024to 1 May 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years
- Capable of giving written informed consent
- Established diagnosis of T2D
- Having established heart or vascular disease defined as either:
- Atherosclerotic disease defined as:
- Prior acute coronary syndrome (ACS).
Show all 14Show fewer
- Chronic coronary syndrome defined as the combination of: Angina pectoris AND coronary atherosclerosis assessed with either Coronary CT angiography (CTA) or Myocardial-scintigraphy (MPI) or Coronary angiography (CAG) AND treatment with statins and/or acetylsalicylic acid.
- Stroke.
- Peripheral arterial disease (PAD) defined as: Claudication intermittence in combination with pathological ABI AND/OR vascular PAD surgery AND/OR ischemic amputation.
- Ischemic heart disease defined by one of the following criteria: a) Myocardial-scintigraphy: >10% reversibility OR b) Coronary CT angiography: Coronary Artery Calcium (CAC)-score >100.
- Heart failure (HF): HF with reduced ejection fraction (HFrEF), HF with Mildly reduced ejection fraction (HFmrEF), HF with preserved ejection fraction (HFpEF)
- Atrial fibrillation and/or flutter, including paroxysmal, persistent and chronic disease
- Valvular heart disease (which requires control in outpatient clinic of cardiology), such as aortic valve stenosis, mitral valve insufficiency, and patients with aortic dilatation
- Hypertension treated with at least three antihypertensive drugs
Who cannot join
- Life expectancy less than 5 years for any reason
- Type 1 Diabetes Mellitus
- Participation in another clinical trial with an investigational product or device that could interfere with the primary and/or secondary endpoints of this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Cardiovascular Research Unit, Odense University Hospital - Svendborg
Svendborg, Region Syddanmark, 5700
Jess Lambrecthsen, Professor
Soeren Auscher, PhD
About this study
Official title: Cardiovascular Protection in Patients With Type 2 Diabetes and Established Heart or Vascular Disease - The Cardio-Metabolic Clinic
This study aims to investigate whether a Cardio-Metabolic Clinic can protect the cardiovascular health of patients with both diabetes and cardiovascular disease.
- At the Cardio-Metabolic Clinic, patients will receive a specialized and comprehensive care. This includes applying a systematic approach, considering their whole health based on the latest knowledge in the field, and administering aggressive treatment with heart protective medications.
- The ProtecT-2-D trial will compare the effects of care at the Cardio-Metabolic Clinic to usual care to see if there are any differences in cardiovascular illness and death.
Read the detailed description
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.
- Conditions
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
- Being tested
- Cardio-Metabolic Clinic
- Keywords
- Cardiovascular death, Heart attack, Stroke, Heart failure, Diabetic microvascular complications, Diabetic macrovascular complications
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases, Myocardial Infarction, Stroke, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardio-Metabolic ClinicOther
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
| Study group | Role | What they receive |
|---|---|---|
| The Cardio-Metabolic Clinic | Active comparator | Comprising specialized, multidisciplinary management of diabetes and cardiovascular disease in a Cardio-Metabolic Clinic. Receives: Other: Cardio-Metabolic Clinic |
| Usual Care | No intervention | Involving collaboration between the general practitioner, and/or the endocrinology outpatient clinic, and/or cardiology outpatient clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 5 years of follow-up
Secondary outcomes (20)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to 3 years of follow-up
Change in urinary albumin-to-creatinine ratio (UACR)
Measured in ratio to baseline.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to 3 years of follow-up
Change in ankle-brachial pressure index (ABI).
Measured in ratio to baseline.
Measured: 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
Measured: 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 [%])
Measured: From baseline to 3 years of follow-up
Net cost analysis of implementing a Cardio-Metabolic Clinic
Measured in dollars [$].
Cost of Cardio-Metabolic Clinic minus averted costs ( including averted admissions, medical treatment, and productivity).
Measured: From baseline to 5 and 10 years of follow-up
Change in health outcomes measured by quality-adjusted life years (QALY)
Measured in score points (change in percentage [%])
Measured: From baseline to 5 and 10 years of follow-up
Cost-effectiveness ratio of implementing a Cardio-Metabolic Clinic
Measured as: Net costs/change in health outcomes [$/QALY]
Measured: From baseline to 5 and 10 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 Jan 2024
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization in the ProtecT-2-D is carried out using the Randomization Module in the electronic Case Report Form (e-CRF) system, REDCap. To ensure concealed allocation the allocation table is created by a REDCap team member, who is independent of the ProtecT-2-D project staff. Participants will be randomized to either the Cardio-Metabolic Clinic or usual care in a ratio of 2:1 1. Cardio-Metabolic Clinic 2. Usual care
- Masking
- None (open label)
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Soeren Auscher, M.D, Ph.D, Principal investigator, Cardiovascular Research Unit. Odense University Hospital, Svendborg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203860
- Sponsor's protocol ID
- ProtecT-2-D
- Acronym
- ProtecT-2-D
- Status last verified
- Jul 2025
- First submitted
- 10 Dec 2023
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Overgaard KS, Mohamed RA, Andersen TR, Lambrechtsen J, Egstrup K, Auscher S. ProtecT-2-D trial protocol: cardiovascular protection in patients with type 2 diabetes and established heart and/or vascular disease at a cardio-metabolic clinic-a randomized controlled trial. Cardiovasc Diabetol. 2024 Jul 8;23(1):241. doi: 10.1186/s12933-024-02340-w.
PubMed 38978117
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Protection in Patients With Type 2 Diabetes and Established Heart or Vascular Disease - The Cardio-Metabolic Clinic
- ClinicalTrials.gov ID
- NCT06203860
- Acronym / sponsor ID
- ProtecT-2-D / ProtecT-2-D
- Conditions
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
- Keywords
- Cardiovascular death, Heart attack, Stroke, Heart failure, Diabetic microvascular complications, Diabetic macrovascular complications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2034 (estimated)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate whether a Cardio-Metabolic Clinic can protect the cardiovascular health of patients with both diabetes and cardiovascular disease.
- At the Cardio-Metabolic Clinic, patients will receive a specialized and comprehensive care. This includes applying a systematic approach, considering their whole health based on the latest knowledge in the field, and administering aggressive treatment with heart protective medications.
- The ProtecT-2-D trial will compare the effects of care at the Cardio-Metabolic Clinic to usual care to see if there are any differences in cardiovascular illness and death.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization in the ProtecT-2-D is carried out using the Randomization Module in the electronic Case Report Form (e-CRF) system, REDCap. To ensure concealed allocation the allocation table is created by a REDCap team member, who is independent of the ProtecT-2-D project staff. Participants will be randomized to either the Cardio-Metabolic Clinic or usual care in a ratio of 2:1 1. Cardio-Metabolic Clinic 2. Usual care
| Arm | Type | Receives |
|---|---|---|
| The Cardio-Metabolic Clinic | Active comparator | Other: Cardio-Metabolic ClinicComprising specialized, multidisciplinary management of diabetes and cardiovascular disease in a Cardio-Metabolic Clinic. |
| Usual Care | No intervention | –Involving collaboration between the general practitioner, and/or the endocrinology outpatient clinic, and/or cardiology outpatient clinic. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- >18 years
- Capable of giving written informed consent
- Established diagnosis of T2D
- Having established heart or vascular disease defined as either:
- Atherosclerotic disease defined as:
Key exclusion criteria (3 listed)
- Life expectancy less than 5 years for any reason
- Type 1 Diabetes Mellitus
- Participation in another clinical trial with an investigational product or device that could interfere with the primary and/or secondary endpoints of this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardio-Metabolic ClinicThe 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 | Other | The Cardio-Metabolic Clinic |
Primary outcome
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).
Time frame: From baseline to 5 years of follow-up
Measured in days.
20 secondary outcomes
Time to first occurrence of MACE, a composite endpoint consisting of: CV death, non-fatal myocardial infarction, non-fatal stroke, and hospitalisation for HF.
Time frame: From baseline to 10 years of follow-up
Time to occurrence of the individual component CV death
Time frame: From baseline to 5 and 10 years of follow-up
Time to occurrence of the individual component AMI.
Time frame: From baseline to 5 and 10 years of follow-up
Time to occurrence of the individual component non-fatal stroke.
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.
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.
Time frame: From baseline to 5 and 10 years of follow-up
Change in diabetic retinopathy stage based on eye examination (fundoscopy)
Time frame: From baseline to 3 years of follow-up
Change in estimated Glomerular Filtration Rate (eGFR)
Time frame: From baseline to 3 years of follow-up
Change in urinary albumin-to-creatinine ratio (UACR)
Time frame: From baseline to 3 years of follow-up
Change in Chronic Kidney Disease (CKD) stage
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
Time frame: From baseline to 3 years of follow-up
Change in fibrosis-4 (FIB-4)
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
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
Time frame: From baseline to 3 years of follow-up
Change in ankle-brachial pressure index (ABI).
Time frame: From baseline to 3 years of follow-up
Change in protocol-driven 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)
Time frame: From baseline to 3 years of follow-up
Net cost analysis of implementing a Cardio-Metabolic Clinic
Time frame: From baseline to 5 and 10 years of follow-up
Change in health outcomes measured by quality-adjusted life years (QALY)
Time frame: From baseline to 5 and 10 years of follow-up
Cost-effectiveness ratio of implementing a Cardio-Metabolic Clinic
Time frame: From baseline to 5 and 10 years of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Derived from this study: PubMed 38978117Overgaard KS, Mohamed RA, Andersen TR, Lambrechtsen J, Egstrup K, Auscher S. ProtecT-2-D trial protocol: cardiovascular protection in patients with type 2 diabetes and established heart and/or vascular disease at a cardio-metabolic clinic-a randomized controlled trial. Cardiovasc Diabetol. 2024 Jul 8;23(1):241. doi: 10.1186/s12933-024-02340-w.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Soeren Auscher, M.D, Ph.D principal investigator
Cardiovascular Research Unit. Odense University Hospital, Svendborg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardio-Metabolic Clinic in people with Diabetes Mellitus, Type 2 and Cardiovascular Diseases, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Soeren Auscher, M.D, Ph.D (+45 6320 2402, Soeren.Auscher@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: From baseline to 5 years of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06203860, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.