Short summary

Patients who suffer from both diabetes type 2 and cardiovascular disease are an especially vulnerable group. Despite great progress in pharmacotherapy throughout the last decades, they often do not succeed in getting a strict control of both diseases. The reason for this is not quite clear, but one of the main reasons may be that they receive a highly fragmented and disease-specific approach in the different out-patients clinics.

Rationale

Concomitant type 2 diabetes and cardiovascular disease are prevalent conditions in Denmark and globally, and patients suffering from the combination of these diseases have a poor prognosis with high risk of comorbidities and impaired quality of life. Strict risk factor control and targeted medical therapy reduces the risk for cardiovascular disease, retinopathy, nephropathy, neuropathy and prolongs life as well as improve quality of life and reduce the disease burden - yet many patients do not achieve these targets. The reasons for this are not clear, yet the complexity and fragmentation of the healthcare system may be a reason, as well as the vulnerability of this patient group.

The DIACOR pilot study is part of a larger research project aiming to improve diagnosis, treatment, and prevention of cardiovascular disease in patients with type 2 diabetes. In the current phase of the project, a hospital-based outpatient clinic has been designed based on guidelines, a literature review, and expert consensus among a multidisciplinary group of healthcare professionals. The next step is to pilot the intervention to assess the feasibility and to better understand the mechanisms involved in the implementation of the research setup. Evaluation of treatment quality will be by a combination of both patient-centered outcomes, using questionnaires and changes in traditional risk factors for cardiovascular disease.

Description of the cohort

Patients with confirmed type 2 diabetes and cardiovascular disease can be included in the pilot study. Eligible patients can be referred to the 'cardio-diabetology' out-patient clinic from other hospital departments, out-patients clinics or from general practice.

Data and biological material

Patient-centered Outcome Measurements including questionnaires (DiabetesPRO, HjertePRO, SF-36, HQL and special designed questionnaires developed to evaluate the 'cardio-diabetology' out-patient clinic) and changes in clinical parameters (traditional cardiovascular risk factors, cardiac structure and function measured by echocardiography, fat composition assessed by DEXA-scan, heart rate measured by Holter, physical activity assessed by accelerometers, and physical capacity assessed 6 minutes walking test). Full blood will be taken for later analyses e.g. of changes in inflammatory markers. National registries will enable evaluation of a possible impact on 4-point major cardiovascular outcome events (non-fatal myocardial infarction, stroke, cardiovascular death and heart failure) and microvascular related diseases (amputations and dialysis).

Collaborating researchers and departments

Department of Cardiology, Holbæk Hospital

• Professor Michael Hecht Olsen, PhD, DMSc

Department of Endocrinology and Cardiology, Slagelse Hospital

• Peter Haulund Gæde, MD, DMSc
• MD, PhD-student Julie Rye Noer Pontoppidan

Department of Endocrinology, Holbæk Sygehus

• JEsper Olund Christensen, MD, PhD

Department of Cardiology, Roskilde Hospital

• PhD, Research Nurse Tina Birgitte Hansen