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

Sponsor
Xiang Guang-da (Other)
Overall Status
Completed
CT.gov ID
NCT02001753
Collaborator
(none)
88
1
3
2
43.2

Study Details

Study Description

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
  • Device: CMR
Phase 4

Study Design

Study Type:
Interventional
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 :
Dec 1, 2013
Actual Primary Completion Date :
Feb 1, 2014
Actual Study Completion Date :
Feb 1, 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Changes of endothelium-dependent arterial dilation before and after CMR in type 2 diabetes [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 [3 days]

    The numbers of endothelial progenitor cells was determined at baseline, 1 day, 2 day, 3 day after CMR.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 65 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Guangda Xiang Wuhan Hubei China 430070

Sponsors and Collaborators

  • Xiang Guang-da

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiang Guang-da, Director of Endocrinology, Wuhan General Hospital, Wuhan General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier:
NCT02001753
Other Study ID Numbers:
  • Wze20130100
First Posted:
Dec 5, 2013
Last Update Posted:
Apr 7, 2014
Last Verified:
Apr 1, 2014
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2014