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

Xiang Guang-da

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes

Treatments: Device: CMR

Study type: Interventional

Funder types: Other

Identifiers

NCT02001753

Wze20130100

Details and patient eligibility

About

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

Enrollment: 88 patients

Sex: Male

Ages: 30 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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88 participants in 3 patient groups, including a placebo group

CMR group

Experimental group

Description:

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

Treatment:

Device: CMR

Placebo group

Placebo Comparator group

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.

Treatment:

Device: CMR

health subject group

No Intervention group

Description:

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