CMR in Type 2 Diabetes Mellitus Patients

Study Overview
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Brief Summary
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The study will be performed as a cross-sectional survey. 300 Type 2 diabetes patients (T2DM), with or without known cardiovascular disease, will be recruited from the diabetes outpatient clinic, Slagelse Hospital. The patients will undergo echocardiography, Cardiac magnetic resonance imaging (CMR), clinical examination and will be asked to fill out questionnaires. This study project sets out to answer the following hypotheses: Patients with T2DM have an increased risk of developing diastolic dysfunction. Using CMR, the investigators wish to measure left ventricle peak filling rate and passive atrial emptying fraction as a measure of cardiac diastolic function. The investigators hypothesize that classic T2DM markers such as levels of urinary albumin excretion, retinopathy, autonomic neuropathy, hypertension, dyslipidemia, elevated HgbA1c, T2DM duration, etc. are associated with pathological findings by CMR. Patients with T2DM have impaired left ventricle myocardial perfusion as determined by gadolinium contrast CMR. The investigators hypothesize that the classic markers and risk factors mentioned above, are associated with left ventricle myocardial hypoperfusion as determined by gadolinium contrast CMR.

Official Title
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Cardiac Magnetic Resonance Imaging in Type 2 Diabetes Mellitus: The Mechanisms of Cardiac Function and Perfusion Dysfunction

Conditions
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Diabetes Mellitus, Type 2, Heart Disease

Intervention / Treatment
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* Other: Cardiac Magnetic Resonance Imaging (CMR)
* Other: Echocardiography
* Other: Bood samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patient fully capable of informed consent Informed consent T2DM Age 18-80 (both years included) Exclusion Criteria: Contraindications to CMR (pacemakers/ICD-units, cochlear implants) Lack of consent Atrial fibrillation eGFR < 30 ml/min/1,73m2 (only exclusion criteria for gadolinium contrast study) Women of childbearing potential who are not on acceptable contraception Severe claustrophobia (only contraindication for CMR but can undergo echocardiography and other examinations) Contraindications to adenosine: history of significant bronchial asthma, 2nd or 3rd degree AV-block, severe hypotension, long QT-syndrome, unstable angina pectoris, sinus node dysfunction, incompensated heart failure Contraindications to glycopyrrolate: closed-angle glaucoma, prostate hyperplasia, tachycardia, bladder atony, cardia insufficiency, non-congenital pylorus stenosis and gastroparesis

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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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| T2DM<br> | Other: Cardiac Magnetic Resonance Imaging (CMR)<br>* An extensive explorative CMR protocol, including time/volume curves of LV and LA, rest and stress perfusion (with Adenosin) and time/volume curve of LA after chronotropic stress with Glycopyrrolate, further flow measurements and T1 mapping.<br>Other: Echocardiography<br>* Standard measurements and strain.<br>Other: Bood samples<br>* HbA1c, Glucose, Hgb, Creatinin, Sodium, Potassium, Total cholesterol, LDL cholesterol, HDL cholesterol, Free fatty acids, ALAT, Urinary albumin, NT-proBNP, ANP, suPAR, Copeptin, Proendothelin, proCNP, Soluble ST2, Galectin-3<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| On CMR; left ventricle peak filling rate (ml/s) | Measure for cardiac diastolic function; including measurements at rest and after glycopyrrolate chronotropic stress | Cross-sectional so at baseline | 
| On CMR, LV myocardial perfusion | Including measurements at rest and with Adenosin stress | Cross-sectional so at baseline | 
| On CMR; passive atrial emptying fraction (%) as a measure for cardiac diastolic function | Measure for cardiac diastolic function; including measurements at rest and after glycopyrrolate chronotropic stress | Cross-sectional so at baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echocardiography | Systolic function | Cross-sectional so at baseline | 
| Blod samples | NT-proBNP, ANP, suPAR, Copeptin, Proendothelin, proCNP, Soluble ST2, Galectin-3 | Cross-sectional so at baseline | 
| Echocardiography | Diastolic function | Cross-sectional so at baseline |