The Cardio-Metabolic Clinic

NCT06203860 | Recruiting DMC

• 1 other identifier: ProtecT-2-D
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases

Keywords

Cardiovascular death; Heart attack; Stroke; Heart failure; Diabetic microvascular complications; Diabetic macrovascular complications

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  From baseline to 10 years of follow-up

• Time to occurrence of the individual component CV death

  From baseline to 5 and 10 years of follow-up

• Time to occurrence of the individual component AMI.

  From baseline to 5 and 10 years of follow-up

• Time to occurrence of the individual component non-fatal stroke.

  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.

  From baseline to 5 and 10 years of follow-up

Study Arms (2)

The Cardio-Metabolic Clinic

ACTIVE COMPARATOR

Comprising specialized, multidisciplinary management of diabetes and cardiovascular disease in a Cardio-Metabolic Clinic.

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.

Interventions

Cardio-Metabolic Clinic OTHER

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

The Cardio-Metabolic Clinic

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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).
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Cardiovascular Research Unit, Odense University Hospital - Svendborg

Svendborg, Region Syddanmark, 5700, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 38978117 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases; Myocardial Infarction; Stroke; Heart Failure

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Myocardial Ischemia; Heart Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Soeren Auscher, M.D, Ph.D

  Cardiovascular Research Unit. Odense University Hospital, Svendborg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soeren Auscher, M.D, Ph.D

CONTACT

+45 6320 2402; Soeren.Auscher@rsyd.dk

Katrine S. Overgaard, M.D

CONTACT

+45 40949749; katrine.schultz.overgaard@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 10, 2023
• First Posted: January 12, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2034
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)