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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.
- Source :
-
Cardiovascular diabetology [Cardiovasc Diabetol] 2024 Jul 08; Vol. 23 (1), pp. 241. Date of Electronic Publication: 2024 Jul 08. - Publication Year :
- 2024
-
Abstract
- Background: Cardiovascular disease remains the primary cause of morbidity and mortality despite advancements in the treatment of patients with type 2 diabetes. Effective diabetes management extends beyond blood glucose control and includes cardiovascular prevention and treatment. However, the conventional healthcare model often emphasizes single-disease-specific management, leading to fragmented care. We aim to establish an affordable Cardio-Metabolic Clinic (CMC) that can provide comprehensive assessment and specialized care with a focus on cardiovascular protection.<br />Methods: The ProtecT-2-D study is a prospective, randomized control trial at the Cardiovascular Research Unit, Odense University Hospital Svendborg, Denmark. In this study, 1500 participants with type 2 diabetes and cardiovascular disease will be randomly assigned in a 2:1 ratio to receive either the intervention: treatment in the CMC, or the control: standard of care. The Cardio-Metabolic Clinic applies a decision-making algorithm coded with the latest guidelines to evaluate lifestyle factors and manage medical treatment. Health examinations are conducted at baseline and after three years, and clinical events will be assessed through registry and journal audits after five and ten years. The primary outcome is the time to the first occurrence of a composite of cardiovascular deaths, non-fatal acute myocardial infarctions, non-fatal stroke, or hospitalization due to heart failure at a time frame of five years.<br />Discussion: The Cardio-Metabolic Clinic represents a pioneering approach to diabetes management that aims to improve patient outcomes by reducing the cardiovascular disease burden. This study could transform diabetes care and offer a multidisciplinary, cost-effective, and specialized treatment. We need to establish the efficacy and feasibility of a CMC to integrate comparable clinics into broader healthcare systems, and potentially enhance cardiovascular health in patients with type 2 diabetes.<br />Trial Registration Number: ClinicalTrials.gov NCT06203860.<br /> (© 2024. The Author(s).)
- Subjects :
- Humans
Prospective Studies
Denmark epidemiology
Time Factors
Treatment Outcome
Randomized Controlled Trials as Topic
Hypoglycemic Agents therapeutic use
Hypoglycemic Agents adverse effects
Delivery of Health Care, Integrated
Heart Disease Risk Factors
Hospitals, University
Ambulatory Care Facilities
Health Care Costs
Risk Assessment
Male
Risk Reduction Behavior
Cost-Benefit Analysis
Biomarkers blood
Diabetes Mellitus, Type 2 diagnosis
Diabetes Mellitus, Type 2 mortality
Diabetes Mellitus, Type 2 complications
Diabetes Mellitus, Type 2 blood
Diabetes Mellitus, Type 2 therapy
Cardiovascular Diseases prevention & control
Cardiovascular Diseases diagnosis
Cardiovascular Diseases mortality
Cardiovascular Diseases epidemiology
Subjects
Details
- Language :
- English
- ISSN :
- 1475-2840
- Volume :
- 23
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Cardiovascular diabetology
- Publication Type :
- Academic Journal
- Accession number :
- 38978117
- Full Text :
- https://doi.org/10.1186/s12933-024-02340-w