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CMR in Type 2 Diabetes Mellitus Patients

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ClinicalTrials.gov Identifier: NCT02684331
Recruitment Status : Completed
First Posted : February 18, 2016
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Annemie Stege Bojer, 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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Heart Disease Other: Cardiac Magnetic Resonance Imaging (CMR) Other: Echocardiography Other: Bood samples

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Study Type : Observational
Actual Enrollment : 296 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Cardiac Magnetic Resonance Imaging in Type 2 Diabetes Mellitus: The Mechanisms of Cardiac Function and Perfusion Dysfunction
Study Start Date : January 2016
Actual Primary Completion Date : July 2019
Actual Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Group/Cohort Intervention/treatment
T2DM 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.

Other: Echocardiography
Standard measurements and strain.

Other: 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




Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
EDTA-plasma Heparin-plasma Serum urine


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

300 T2DM patients, with or without known cardiovascular disease, will be recruited from the diabetes outpatient clinic, Slagelse Hospital.

The patients will be divided into groups depending on their diabetes complication status. Individual groups of patients with fx. +/- retinopathy, +/- autonomous neuropathy, +/- hypertension, normo-/mikro-/makroalbuminuria will be compared.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02684331


Locations
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Denmark
The diabetes outpatient clinic, Slagelse Hospital, Denmark
Slagelse, Denmark, 4200
Sponsors and Collaborators
Slagelse Hospital
Investigators
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Principal Investigator: Martin H Soerensen, DM Slagelse Hospital

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Responsible Party: Annemie Stege Bojer, Clinical assistant, Slagelse Hospital
ClinicalTrials.gov Identifier: NCT02684331     History of Changes
Other Study ID Numbers: SJ-490
First Posted: February 18, 2016    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Heart Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases