CMR in Type 2 Diabetes Mellitus Patients

Completed

• Conditions: Diabetes Mellitus, Type 2; Heart Disease
• Interventions: Other: Cardiac Magnetic Resonance Imaging (CMR); Other: Echocardiography; Other: Bood samples

• Registration Number: NCT02684331
• Lead Sponsor: Slagelse Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-02-08
• Study First Submitted QC: 2016-02-11
• Study First Posted: 2016-02-18
• Primary Completion: 2019-07
• Study Completion: 2019-07
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-18
• Last Update Posted: 2019-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 296

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
T2DM	Echocardiography	-
T2DM	Bood samples	-
T2DM	Cardiac Magnetic Resonance Imaging (CMR)	-

Primary Outcome Measures

Name	Time	Method
On CMR; left ventricle peak filling rate (ml/s)	Cross-sectional so at baseline	Measure for cardiac diastolic function; including measurements at rest and after glycopyrrolate chronotropic stress
On CMR, LV myocardial perfusion	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	Cross-sectional so at baseline	Measure for cardiac diastolic function; including measurements at rest and after glycopyrrolate chronotropic stress

Secondary Outcome Measures

Name	Time	Method
Echocardiography	Cross-sectional so at baseline	Diastolic function
Blod samples	Cross-sectional so at baseline	NT-proBNP, ANP, suPAR, Copeptin, Proendothelin, proCNP, Soluble ST2, Galectin-3

Trial Locations

Locations (1)

The diabetes outpatient clinic, Slagelse Hospital, Denmark; 🇩🇰 Slagelse, Denmark