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CMR in Type 2 Diabetes Mellitus Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02684331
Enrollment
296
Registered
2016-02-18
Start date
2016-01-31
Completion date
2019-07-31
Last updated
2019-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Heart Disease

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.

Interventions

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.

OTHEREchocardiography

Standard measurements and strain.

OTHERBood 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

Sponsors

Slagelse Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
On CMR; left ventricle peak filling rate (ml/s)Cross-sectional so at baselineMeasure for cardiac diastolic function; including measurements at rest and after glycopyrrolate chronotropic stress
On CMR, LV myocardial perfusionCross-sectional so at baselineIncluding measurements at rest and with Adenosin stress
On CMR; passive atrial emptying fraction (%) as a measure for cardiac diastolic functionCross-sectional so at baselineMeasure for cardiac diastolic function; including measurements at rest and after glycopyrrolate chronotropic stress

Secondary

MeasureTime frameDescription
EchocardiographyCross-sectional so at baselineSystolic function
Blod samplesCross-sectional so at baselineNT-proBNP, ANP, suPAR, Copeptin, Proendothelin, proCNP, Soluble ST2, Galectin-3

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026