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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
CMR
Sponsored by
Xiang Guang-da
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type 2 Diabetes

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Guangda Xiang

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

CMR group

Placebo group

health subject group

Arm Description

Endothelial function, oxidative stress and inflammation were measured before and after CMR.

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.

Healthy subjects (30) will be enrolled as controls at baseline.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 23, 2013
Last Updated
April 3, 2014
Sponsor
Xiang Guang-da
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1. Study Identification

Unique Protocol Identification Number
NCT02001753
Brief Title
Impact of Cardiac Magnetic Resonance Imaging on Endothelial Function in Type 2 Diabetes
Official Title
Impact of Cardiac Magnetic Resonance Imaging on Endothelial Function in Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiang Guang-da

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CMR group
Arm Type
Experimental
Arm Description
Endothelial function, oxidative stress and inflammation were measured before and after CMR.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
health subject group
Arm Type
No Intervention
Arm Description
Healthy subjects (30) will be enrolled as controls at baseline.
Intervention Type
Device
Intervention Name(s)
CMR
Primary Outcome Measure Information:
Title
Changes of endothelium-dependent arterial dilation before and after CMR in type 2 diabetes
Description
The endothelium-dependent arterial dilation was measured at baseline, 1day, 2 day, 3 day after CMR.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Changes of endothelial progenitor cells before and after CMR in peripheral blood
Description
The numbers of endothelial progenitor cells was determined at baseline, 1 day, 2 day, 3 day after CMR.
Time Frame
3 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Guangda Xiang
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430070
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
25602854
Citation
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.
Results Reference
derived

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

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