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

Phase 4

Completed

• Conditions: Type 2 Diabetes
• Interventions: Device: CMR

• Registration Number: NCT02001753
• Lead Sponsor: Xiang Guang-da

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 available

Study Timeline

• Study First Submitted: 2013-11-23
• Study Start: 2013-12
• Study First Submitted QC: 2013-12-04
• Study First Posted: 2013-12-05
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-03
• Last Update Posted: 2014-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	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.
CMR group	CMR	Endothelial function, oxidative stress and inflammation were measured before and after CMR.

Primary Outcome Measures

Name	Time	Method
Changes of endothelium-dependent arterial dilation before and after CMR in type 2 diabetes	3 days	The endothelium-dependent arterial dilation was measured at baseline, 1day, 2 day, 3 day after CMR.

Secondary Outcome Measures

Name	Time	Method
Changes of endothelial progenitor cells before and after CMR in peripheral blood	3 days	The numbers of endothelial progenitor cells was determined at baseline, 1 day, 2 day, 3 day after CMR.

Trial Locations

Locations (1)

Guangda Xiang; 🇨🇳 Wuhan, Hubei, China