Short summary

The purpose of this study is to explore whether implementing a systematic, specialized, multidisciplinary approach within a Cardio-Metabolic Clinic for patients diagnosed with type 2 diabetes and cardiovascular disease will lead to improved diabetes management and decreased incidence of cardiovascular morbidity and mortality, as compared to standard care.

Rationale

Despite improved treatment options, cardiovascular disease remains the leading cause of illness and death among patients with type 2 diabetes. Diabetes is not just a disease that requires managing blood sugar levels; there should also be a significant focus on treating and preventing cardiovascular disease. It has been proven that focus on lifestyle has a significant effect on cardiovascular disease. Additionally, there has been remarkable advancements over the past 5 years in treatment options with cardiovascular protective effects. Therefore, we aim to establish a Cardio-Metabolic Clinic that will ensure an interdisciplinary optimization of diabetes treatment, with a special focus on cardiovascular protective measures.

This study is a prospective, randomly assigned, controlled trial in which the participants will be assigned to either the Cardio-Metabolic Clinic or standard treatment in a ratio of 2:1. The population will consist of patients with type 2 diabetes and known heart or vascular disease, seen in the cardiology or endocrinology outpatient clinics. We expect approximately 1750 participants to take part in the study. All participants will be examined at the start. Patients who enter the Cardio-Metabolic Clinic will undergo a thorough interdisciplinary evaluation and will be optimized regarding lifestyle factors and medical treatment based on current treatment guidelines. After 3 years, all participants will be reexamined. At 5 and 10 years, complications attributed to the participants' diabetes or cardiovascular disease will be assessed through register and journal audit.

The objectives of the study are to investigate whether patients with type 2 diabetes receiving optimal diabetes treatment in a Cardio-Metabolic Clinic are more beneficial compared to standard treatment, as evaluated by: 1) the incidence of cardiovascular death, heart attack, stroke, heart failure, or hospitalization due to heart failure; 2) the incidence of microvascular complications such as diabetic eye or kidney disease; and 3) the incidence of macrovascular complications such as peripheral artery disease or coronary artery disease.

Our hypothesis is that patients with type 2 diabetes and cardiovascular disease receiving optimal diabetes treatment in a Cardio-Metabolic Clinic will achieve better diabetes treatment and consequently experience fewer cases of cardiovascular disease and death compared to standard treatment.

Description of the cohort

The population will consist of patients with type 2 diabetes and known heart or vascular disease, seen in the cardiology or endocrinology outpatient clinics at OUH Svendborg Hospital.

Data and biological material

Biochemistry: Blood and urine samples will be collected at baseline and 3 year follow up visits. Data: Baseline visit and 3 year follow-up visit: Data will be collected from patient journals, questionnaires and Danish Adult Diabetes Database (DVDD). 5 and 10 years follow-up: Data will be collected from journal audit and national registries (Danish Health Data Authority).

Collaborating researchers and departments

We will facilitate a multidisciplinary collaboration involving various departments within the internal medicine division at Svendborg Hospital.