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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

Tracking Information
First Submitted Date  ICMJE November 23, 2013
First Posted Date  ICMJE December 5, 2013
Last Update Posted Date April 7, 2014
Study Start Date  ICMJE December 2013
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 4, 2013)
Changes of endothelium-dependent arterial dilation before and after CMR in type 2 diabetes [ Time Frame: 1 week ]
The endothelium-dependent arterial dilation was measured at baseline, 1day, 2 day, 3 day and 7 day after CMR.
Change History Complete list of historical versions of study NCT02001753 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2014)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2013)
Changes of endothelial progenitor cells before and after CMR in peripheral blood [ Time Frame: 1 week ]
The numbers of endothelial progenitor cells was determined at baseline, 1 day, 2 day, 3 day and 7 day after CMR.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: December 4, 2013)
Changes of endothelium-dependent arterial dilation induced by CMR before and after alpha lipoic acid. [ Time Frame: 1 week ]
Alpha lipoic acid 600 mg will be given 1 hour before CMR in alpha lipoic acid group. At baseline, 1 day, 2 day, 3 day and 7 day after CMR, endothelium-dependent arterial dilation will be measured for this group.
 
Descriptive Information
Brief Title  ICMJE Impact of Cardiac Magnetic Resonance Imaging on Endothelial Function in Type 2 Diabetes
Official Title  ICMJE Impact of Cardiac Magnetic Resonance Imaging on Endothelial Function in Type 2 Diabetes
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE Device: CMR
Study Arms  ICMJE
  • Experimental: CMR group
    Endothelial function, oxidative stress and inflammation were measured before and after CMR.
    Intervention: 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.
    Intervention: Device: CMR
  • No Intervention: health subject group
    Healthy subjects (30) will be enrolled as controls at baseline.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 3, 2014)
88
Original Estimated Enrollment  ICMJE
 (submitted: December 4, 2013)
60
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02001753
Other Study ID Numbers  ICMJE Wze20130100
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xiang Guang-da, Wuhan General Hospital of Guangzhou Military Command
Study Sponsor  ICMJE Xiang Guang-da
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Wuhan General Hospital of Guangzhou Military Command
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP