CMR in Type 2 Diabetes Mellitus Patients

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02684331
• Other study ID #: SJ-490
• Status: Completed
• Start date: January 2016
• Est. completion date: July 2019

Study information

• Verified date: September 2019
• Source: Slagelse Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Heart Disease
• Heart Diseases

Intervention

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.
• Echocardiography
Standard measurements and strain.
• 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

Locations

Country	Name	City	State
Denmark	The diabetes outpatient clinic, Slagelse Hospital, Denmark	Slagelse

Sponsors (1)

Lead Sponsor	Collaborator
Slagelse Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	On CMR, LV myocardial perfusion	Including measurements at rest and with Adenosin stress	Cross-sectional so at baseline
Primary	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	Echocardiography	Systolic function	Cross-sectional so at baseline
Secondary	Blod samples	NT-proBNP, ANP, suPAR, Copeptin, Proendothelin, proCNP, Soluble ST2, Galectin-3	Cross-sectional so at baseline
Secondary	Echocardiography	Diastolic function	Cross-sectional so at baseline