Impact of Cardiac Magnetic Resonance Imaging on Endothelial Function in Type 2 Diabetes

Study Overview
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Brief Summary
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Magnetic resonance (MR) imaging is a widely used and well-established noninvasive medical diagnostic imaging tool. By using a static and a gradient magnetic field in combination with a radiofrequency field (RF), MR provides excellent contrast among different tissues of the body. Although long-term effects on human health from exposure to strong static magnetic fields seem unlikely, acute effects such as vertigo, nausea, change in blood pressure, reversible arrhythmia, and neurobehavioural effects have been documented from occupational exposition to 1.5 T. Cardiac MR (CMR) imaging requires some of the strongest and fastest switching electromagnetic gradients available in MR exposing the patients to the highest administered energy levels accepted by the controlling authorities. Studies focusing on experimental teratogenic or carcinogenic effects of MR revealed conflicting results. Since CMR is emerging as one of the fastest growing new fields of broad MR application, it is of particular concern that a recent in vitro study with CMR sequences has reported on CMR-induced DNA damages in white blood cells up to 24 h after exposure to 1.5 T CMR. Therefore, we hypothesized that CMR can induce the damage of endothelium and endothelial progenitor cells in type 2 diabetes

Official Title
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Impact of Cardiac Magnetic Resonance Imaging on Endothelial Function in Type 2 Diabetes

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Device: CMR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male Age 30 to 65 years old Type 2 diabetes Exclusion Criteria: Renal and liver function dysfunction Heart failure Malignancy Patients with contraindications to cardiac magnetic resonance (CMR) Patients with clinical detectable angiopathy

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CMR group<br>Endothelial function, oxidative stress and inflammation were measured before and after CMR. | Device: CMR<br> <br> |
| Placebo Comparator: Placebo group<br>The subjects keep supine position the MR machine as same time as experimental group when the MR machine is power off. The endothelial function, oxidative stress and inflammation were measured before and after this procedure. This group is called the non-CMR group or sham CMR group. | Device: CMR<br> <br> |
| No Intervention: health subject group<br>Healthy subjects (30) will be enrolled as controls at baseline. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of endothelium-dependent arterial dilation before and after CMR in type 2 diabetes | The endothelium-dependent arterial dilation was measured at baseline, 1day, 2 day, 3 day after CMR. | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of endothelial progenitor cells before and after CMR in peripheral blood | The numbers of endothelial progenitor cells was determined at baseline, 1 day, 2 day, 3 day after CMR. | 3 days |