CMR in Type 2 Diabetes Mellitus Patients

• Sponsor: Slagelse Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02684331
• Collaborator: (none)
• Enrollment: 296
• Location: 1
• Duration (Months): 42
• Patients Per Site Per Month: 7.1

Study Details

Study Description

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	Phase
Diabetes Mellitus, Type 2; Heart Disease	Other: Cardiac Magnetic Resonance Imaging (CMR); Other: Echocardiography; Other: Bood samples

Study Design

• 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: Jan 1, 2016
• Actual Primary Completion Date: Jul 1, 2019
• Actual Study Completion Date: Jul 1, 2019

Arms and Interventions

Arm

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

Outcome Measures

Primary Outcome Measures

1. On CMR; left ventricle peak filling rate (ml/s) [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 [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 [Cross-sectional so at baseline]

   Measure for cardiac diastolic function; including measurements at rest and after glycopyrrolate chronotropic stress

Secondary Outcome Measures

1. Echocardiography [Cross-sectional so at baseline]

   Systolic function

2. Blod samples [Cross-sectional so at baseline]

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

3. Echocardiography [Cross-sectional so at baseline]

   Diastolic function

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The diabetes outpatient clinic, Slagelse Hospital, Denmark	Slagelse		Denmark	4200

Sponsors and Collaborators

• Slagelse Hospital

Investigators

• Principal Investigator: Martin H Soerensen, DM, Slagelse Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Annemie Stege Bojer, Clinical assistant, Slagelse Hospital
• ClinicalTrials.gov Identifier: NCT02684331
• Other Study ID Numbers: SJ-490
• First Posted: Feb 18, 2016
• Last Update Posted: Sep 19, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Heart Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Sep 19, 2019