NCT02001753

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for phase_4 type-2-diabetes

Timeline
Completed

Started Dec 2013

Shorter than P25 for phase_4 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2013

Completed
8 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

April 7, 2014

Status Verified

April 1, 2014

Enrollment Period

2 months

First QC Date

November 23, 2013

Last Update Submit

April 3, 2014

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Changes of endothelial progenitor cells before and after CMR in peripheral blood

    3 days

Study Arms (3)

CMR group

EXPERIMENTAL

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

Device: CMR

Placebo group

PLACEBO COMPARATOR

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.

Device: CMR

health subject group

NO INTERVENTION

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

Interventions

CMRDEVICE
CMR groupPlacebo group

Eligibility Criteria

Age30 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • Age 30 to 65 years old
  • Type 2 diabetes

You may not qualify if:

  • Renal and liver function dysfunction
  • Heart failure
  • Malignancy
  • Patients with contraindications to cardiac magnetic resonance (CMR)
  • Patients with clinical detectable angiopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangda Xiang

Wuhan, Hubei, 430070, China

Location

Related Publications (1)

  • 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.

    PMID: 25602854DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Endocrinology, Wuhan General Hospital

Study Record Dates

First Submitted

November 23, 2013

First Posted

December 5, 2013

Study Start

December 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

April 7, 2014

Record last verified: 2014-04

Locations

CN(1)