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Completed

NCT Number: NCT02001753

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

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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Key information

Age range

30 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Guangda Xiang

Wuhan, Hubei, 430070, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CMR

Device

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Xiang Guang-da

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 5, 2013
Registry last updated
Apr 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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