CMR in Type 2 Diabetes Mellitus Patients
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|ClinicalTrials.gov Identifier: NCT02684331|
Recruitment Status : Completed
First Posted : February 18, 2016
Last Update Posted : September 19, 2019
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.
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus, Type 2 Heart Disease||Other: Cardiac Magnetic Resonance Imaging (CMR) Other: Echocardiography Other: Bood samples|
|Study Type :||Observational|
|Actual Enrollment :||296 participants|
|Official Title:||Cardiac Magnetic Resonance Imaging in Type 2 Diabetes Mellitus: The Mechanisms of Cardiac Function and Perfusion Dysfunction|
|Study Start Date :||January 2016|
|Actual Primary Completion Date :||July 2019|
|Actual Study Completion Date :||July 2019|
Other: Cardiac Magnetic Resonance Imaging (CMR)
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.
Standard measurements and strain.
Other: Bood samples
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
- On CMR; left ventricle peak filling rate (ml/s) [ Time Frame: Cross-sectional so at baseline ]Measure for cardiac diastolic function; including measurements at rest and after glycopyrrolate chronotropic stress
- On CMR, LV myocardial perfusion [ Time Frame: Cross-sectional so at baseline ]Including measurements at rest and with Adenosin stress
- On CMR; passive atrial emptying fraction (%) as a measure for cardiac diastolic function [ Time Frame: Cross-sectional so at baseline ]Measure for cardiac diastolic function; including measurements at rest and after glycopyrrolate chronotropic stress
- Echocardiography [ Time Frame: Cross-sectional so at baseline ]Systolic function
- Blod samples [ Time Frame: Cross-sectional so at baseline ]NT-proBNP, ANP, suPAR, Copeptin, Proendothelin, proCNP, Soluble ST2, Galectin-3
- Echocardiography [ Time Frame: Cross-sectional so at baseline ]Diastolic function
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02684331
|The diabetes outpatient clinic, Slagelse Hospital, Denmark|
|Slagelse, Denmark, 4200|
|Principal Investigator:||Martin H Soerensen, DM||Slagelse Hospital|