- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02001753
Impact of Cardiac Magnetic Resonance Imaging on Endothelial Function in Type 2 Diabetes
April 3, 2014 updated by: Xiang Guang-da
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
Study Overview
Study Type
Interventional
Enrollment (Actual)
88
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hubei
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Wuhan, Hubei, China, 430070
- Guangda Xiang
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CMR group
Endothelial function, oxidative stress and inflammation were measured before and after CMR.
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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.
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No Intervention: health subject group
Healthy subjects (30) will be enrolled as controls at baseline.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of endothelium-dependent arterial dilation before and after CMR in type 2 diabetes
Time Frame: 3 days
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The endothelium-dependent arterial dilation was measured at baseline, 1day, 2 day, 3 day after CMR.
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3 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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3 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
November 23, 2013
First Submitted That Met QC Criteria
December 4, 2013
First Posted (Estimate)
December 5, 2013
Study Record Updates
Last Update Posted (Estimate)
April 7, 2014
Last Update Submitted That Met QC Criteria
April 3, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Wze20130100
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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