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CompletedNCT02001753Updated Apr 7, 2014

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

A Phase 4 interventional study of CMR in Type 2 Diabetes, sponsored by Xiang Guang-da. Completed at 1 site in China. Open to male participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-04-07.

Sponsored by Xiang Guang-da · Phase 4, Interventional, and Health services research

Phase
Phase 4
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
30 Years to 65 Years
Sex
Male
01

Study 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

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Conditions studied

03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 88 is close to the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Xiang Guang-da is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male
  • Age 30 to 65 years old
  • Type 2 diabetes

Exclusion criteria

Exclusion Criteria:

  • Renal and liver function dysfunction
  • Heart failure
  • Malignancy
  • Patients with contraindications to cardiac magnetic resonance (CMR)
  • Patients with clinical detectable angiopathy
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Study design

Phase
Phase 4
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
88 participants (actual)

Study arms

  • 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.

Interventions

  • DeviceCMR
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 days

Secondary outcomes

  1. 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.

    Time frame: 3 days

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Study locations

1 site
  • Guangda Xiang
    Wuhan, Hubei 430070, China
08

References and documents

Publications

  • Xiang G, Xiang L, He H, Zhang J, Dong J. Impact of cardiac magnetic resonance on endothelial function in type 2 diabetic patients. Atherosclerosis. 2015 Mar;239(1):131-6. doi: 10.1016/j.atherosclerosis.2014.12.028. Epub 2015 Jan 13. PubMed 25602854 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02001753
Lead sponsor
Xiang Guang-da
Responsible party
Xiang Guang-da (Director of Endocrinology, Wuhan General Hospital, Wuhan General Hospital of Guangzhou Military Command) — Sponsor-investigator
First posted
Dec 5, 2013
Start date
Dec 2013
Primary completion
Feb 2014
Completion
Feb 2014
Last update
Apr 7, 2014

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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