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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02001753
• Other study ID #: Wze20130100
• Status: Completed
• Phase: Phase 4
• First received: November 23, 2013
• Last updated: April 3, 2014
• Start date: December 2013
• Est. completion date: February 2014

Study information

• Verified date: April 2014
• Source: Wuhan General Hospital of Guangzhou Military Command
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Device:
• CMR

Locations

Country	Name	City	State
China	Guangda Xiang	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Xiang Guang-da

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 days	Yes
Secondary	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.	3 days	Yes