Clinical trial NCT02684331: CMR in Type 2 Diabetes Mellitus Patients
Official title: Cardiac Magnetic Resonance Imaging in Type 2 Diabetes Mellitus: The Mechanisms of Cardiac Function and Perfusion Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Heart Disease
Lead sponsor: Slagelse Hospital
Sponsor class: OTHER
First posted: 2016-02-18
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility 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

Primary outcomes:
measure: On CMR; left ventricle peak filling rate (ml/s)
timeFrame: Cross-sectional so at baseline
measure: On CMR, LV myocardial perfusion
timeFrame: Cross-sectional so at baseline
measure: On CMR; passive atrial emptying fraction (%) as a measure for cardiac diastolic function
timeFrame: Cross-sectional so at baseline
Secondary outcomes:
measure: Echocardiography
timeFrame: Cross-sectional so at baseline
measure: Blod samples
timeFrame: Cross-sectional so at baseline
measure: Echocardiography
timeFrame: Cross-sectional so at baseline
Other outcomes:
Locations:
city: Slagelse
country: Denmark
facility: The diabetes outpatient clinic, Slagelse Hospital, Denmark
Study officials:
affiliation: Slagelse Hospital
name: Martin H Soerensen, DM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bojer AS, Sorensen MH, Vejlstrup N, Goetze JP, Gaede P, Madsen PL. Distinct non-ischemic myocardial late gadolinium enhancement lesions in patients with type 2 diabetes. Cardiovasc Diabetol. 2020 Oct 22;19(1):184. doi: 10.1186/s12933-020-01160-y.
citation: Sorensen MH, Bojer AS, Jorgensen NR, Broadbent DA, Plein S, Madsen PL, Gaede P. Fibroblast growth factor-23 is associated with imaging markers of diabetic cardiomyopathy and anti-diabetic therapeutics. Cardiovasc Diabetol. 2020 Sep 30;19(1):158. doi: 10.1186/s12933-020-01135-z.
citation: Sorensen MH, Bojer AS, Pontoppidan JRN, Broadbent DA, Plein S, Madsen PL, Gaede P. Reduced Myocardial Perfusion Reserve in Type 2 Diabetes Is Caused by Increased Perfusion at Rest and Decreased Maximal Perfusion During Stress. Diabetes Care. 2020 Jun;43(6):1285-1292. doi: 10.2337/dc19-2172. Epub 2020 Mar 19.
citation: Sorensen MH, Bojer AS, Broadbent DA, Plein S, Madsen PL, Gaede P. Cardiac perfusion, structure, and function in type 2 diabetes mellitus with and without diabetic complications. Eur Heart J Cardiovasc Imaging. 2020 Aug 1;21(8):887-895. doi: 10.1093/ehjci/jez266.