CMR in T2DM: The NSR Cohort

Study Overview
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Brief Summary
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This study aims to investigate the myocardial phenotype of patients with type 2 diabetes. From 2016-2019 the investigators recruited a cohort of 296 subjects with type 2 diabetes. All subjects underwent clinical examinations including a gadolinium contrast cardiac MRI. The current study is a clinical follow-up study of the subjects, thus, the investigators will invite all participants to a reevaluation with cardiac MRI. Additionally, the investigators will aim at recruiting additionally 400 patients with type 2 diabetes. The aim it to characterize the phenotype of diabetic cardiomyopathy. Uniquely using cardiac MRI we can measure myocardial microvascular function, myocardial localised and diffuse fibrosis in addition to the quantification of myocardial structure and systolic and diastolic function.

Official Title
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Cardiac Magnetic Resonance Imaging in Type 2 Diabetes Mellitus: The Næstved/Slagelse/Ringsted Cohort

Conditions
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Diabetes Mellitus, Type 2, Diabetic Cardiomyopathies, Cardiovascular Magnetic Resonance Imaging, Coronary Microvascular Dysfunction, Myocardium; Fibrosis

Intervention / Treatment
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* Diagnostic Test: All subjects will undergo cardiac magnetic resonance imaging with gadolinium contrast and with adenosine myocardial perfusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Few and simple, allowing for a broad cohort. Male or female fully capable of providing informed consent Informed consent Age 18-80 (both included) T2DM diagnosed at least 3 months prior to inclusion in the study Exclusion Criteria:

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with type 2 diabetes<br>This group will be split up into different groups. DM2 with vs. without complications to diabetes DM2 with vs. without albuminuria/nephropathy or autonomic neuropathy or retinopathy or peripheral neuropathy or macrovascular angiopathy | Diagnostic Test: All subjects will undergo cardiac magnetic resonance imaging with gadolinium contrast and with adenosine myocardial perfusion<br>* This is a observational follow up study accordingly all subjects will undergo the same examinations<br>* Other names: Examination for non cardiac complications to diabetes;|
| sex and age matched control subjects<br> | Diagnostic Test: All subjects will undergo cardiac magnetic resonance imaging with gadolinium contrast and with adenosine myocardial perfusion<br>* This is a observational follow up study accordingly all subjects will undergo the same examinations<br>* Other names: Examination for non cardiac complications to diabetes;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of myocardial microvascular function in patients with type 2 diabetes with MACE after 5 years | Myocardial microvascular function is measured by the myocardial perfusion ratio, quantified by cardiac MRI. MACE defined as CVD events (AMI, HF, stable angina, atrial fibrillation, ventricular arytmia), stroke, death | 5 years follow-up | 
| Clinical factors associated with worsening of diabetic cardiomyopathy after 5 years | Clinical factors :Albuminuria, autonomic neuropathy, retinopathy, HbA1c, hs-CRP. Signs of worsening af diabetic cardiomyopathy: Increased myocardial extracellular volume, decreased myocardial blood flow and myocardial perfusion reserve, decreased strain (GLS; GCS, GRS), increasing E/e´, increasing concentri remodeling index(LV mass / LV end-diastolic volume) | 5 years follow-up | 
| Impact of myocardial perfusion and cardiac cardiac output on perfusion in other organs (kidney, spleen, liver) assed by gadolinium contrast magnetic resonance imaging | Myocardial perfusion measured by myocardial blood flow and myocardial perfusion ratio quantified by cardiac MRI. | Baseline and at 5 years follow-up | 
| The association of pericardial- and epicardial fat with myocardial function and MACE after 5 year | Myocardial function: LVEF, LV strain (GLS, GCS, GRS), E/e´, myocardial extracellular volume, myocardial perfusion ratio. MACE defined as CVD events (AMI, HF, stable angina, atrial fibrillation, ventricular arytmia), stroke, death | Baseline and at 5 years follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of the progression of diabetic cardiomyopathy over 5 years, including LV+RV function, the coronary microvascular function, the coronary macrovascular function, fibrosis, aortic stiffness, per and epicardial fat, perfusion of other organs | Using multivariable regression including age, sex, smoking, Hypertension, HbA1c, CRP, blood pressure, albuminuria, autonomic neuropathy, retinopathy factors associated with either progression or regression of diabetic cardiomyopathy will be tested. Progression of diabetic cardiomyopathy will be defined as increasing myocardial extracellular volume, decreasing myocardial perfusion reserve, decreasing strain (GLS, GCS, GRS), increasing E/e´compared to baseline. | 5 years follow-up |