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Clinical Trials/NCT02001753
NCT02001753
Completed
Phase 4

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

Xiang Guang-da1 site in 1 country88 target enrollmentDecember 2013
ConditionsType 2 Diabetes

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Type 2 Diabetes
Sponsor
Xiang Guang-da
Enrollment
88
Locations
1
Primary Endpoint
Changes of endothelium-dependent arterial dilation before and after CMR in type 2 diabetes
Status
Completed
Last Updated
12 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
December 2013
End Date
February 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Xiang Guang-da
Responsible Party
Sponsor Investigator
Principal Investigator

Xiang Guang-da

Director of Endocrinology, Wuhan General Hospital

Wuhan General Hospital of Guangzhou Military Command

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

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 Outcomes

  • Changes of endothelial progenitor cells before and after CMR in peripheral blood(3 days)

Study Sites (1)

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