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NCT Number: NCT02684331

CMR in Type 2 Diabetes Mellitus Patients

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Disease Heart Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The diabetes outpatient clinic, Slagelse Hospital, Denmark

Slagelse, 4200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac magnetic resonance imaging (CMR)

Other

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

Other

Standard measurements and strain.

Bood samples

Other

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

Primary outcomes

  1. 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

  2. On CMR, LV myocardial perfusion

    Time frame: Cross-sectional so at baseline

    Including measurements at rest and with Adenosin stress

  3. 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

Secondary outcomes

  1. Echocardiography

    Time frame: Cross-sectional so at baseline

    Systolic function

  2. Blod samples

    Time frame: Cross-sectional so at baseline

    NT-proBNP, ANP, suPAR, Copeptin, Proendothelin, proCNP, Soluble ST2, Galectin-3

  3. Echocardiography

    Time frame: Cross-sectional so at baseline

    Diastolic function

Sponsors and collaborators

Lead sponsor

Slagelse Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 18, 2016
Registry last updated
Sep 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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