CMR in Type 2 Diabetes Mellitus Patients

Slagelse Hospital

Status: Completed

Conditions: Diabetes Mellitus, Type 2; Heart Disease

Treatments: Other: Cardiac Magnetic Resonance Imaging (CMR); Other: Bood samples; Other: Echocardiography

Study type: Observational

Funder types: Other

Identifiers

NCT02684331

SJ-490

Details and patient eligibility

About

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:

1. 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.
2. 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.

Enrollment: 296 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

296 participants in 1 patient group

T2DM

Treatment:

Other: Bood samples

Other: Cardiac Magnetic Resonance Imaging (CMR)

Other: Echocardiography