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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-02-28

Brief Summary

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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

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Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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CMR group

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

Group Type EXPERIMENTAL

CMR

Intervention Type DEVICE

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.

Group Type PLACEBO_COMPARATOR

CMR

Intervention Type DEVICE

health subject group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CMR

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes