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

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ClinicalTrials.gov Identifier: NCT02001753
Recruitment Status : Completed
First Posted : December 5, 2013
Last Update Posted : April 7, 2014
Sponsor:
Information provided by (Responsible Party):
Xiang Guang-da, Wuhan General Hospital of Guangzhou Military Command

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Device: CMR Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Impact of Cardiac Magnetic Resonance Imaging on Endothelial Function in Type 2 Diabetes
Study Start Date : December 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arm Intervention/treatment
Experimental: CMR group
Endothelial function, oxidative stress and inflammation were measured before and after CMR.
Device: CMR
Placebo Comparator: Placebo group
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
No Intervention: health subject group
Healthy subjects (30) will be enrolled as controls at baseline.



Primary Outcome Measures :
  1. Changes of endothelium-dependent arterial dilation before and after CMR in type 2 diabetes [ Time Frame: 3 days ]
    The endothelium-dependent arterial dilation was measured at baseline, 1day, 2 day, 3 day after CMR.


Secondary Outcome Measures :
  1. Changes of endothelial progenitor cells before and after CMR in peripheral blood [ Time Frame: 3 days ]
    The numbers of endothelial progenitor cells was determined at baseline, 1 day, 2 day, 3 day after CMR.



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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02001753


Locations
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China, Hubei
Guangda Xiang
Wuhan, Hubei, China, 430070
Sponsors and Collaborators
Xiang Guang-da

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Xiang Guang-da, Director of Endocrinology, Wuhan General Hospital, Wuhan General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier: NCT02001753     History of Changes
Other Study ID Numbers: Wze20130100
First Posted: December 5, 2013    Key Record Dates
Last Update Posted: April 7, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases