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Detection of Vascular Injury in Diabetes Through Eye and Nailfold Data (DIVIDEND) - A Pilot Study

This study has been completed.
Sponsor:
Information provided by:
John Hunter Hospital
ClinicalTrials.gov Identifier:
NCT01279928
First received: January 19, 2011
Last updated: January 24, 2011
Last verified: January 2011
History of Changes

January 19, 2011
January 24, 2011
March 2010
September 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01279928 on ClinicalTrials.gov Archive Site
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Detection of Vascular Injury in Diabetes Through Eye and Nailfold Data (DIVIDEND) - A Pilot Study
Detection of Vascular Injury in Diabetes Through Eye and Nailfold Data (DIVIDEND) - A Pilot Study

This project aimed to explore novel methods of detecting small blood vessel disease in a paediatric population with type 1 diabetes mellitus. To do this the techniques of Nailfold capillaroscopy, laser Doppler flowmetry, retinal (eye) vessel analysis and 24-hr Ambulatory Blood Pressure Monitoring were used. Each of these techniques investigated different areas of small blood vessels around the body.

It was hypothesized that in a paediatric population with type 1 diabetes mellitus the novel investigations would be associated with small blood vessel disease and that widespread changes to these blood vessels would be detected through associations between the different novel investigations.
Not Provided
Observational
Time Perspective: Cross-Sectional
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Non-Probability Sample

Participants were recruited from the John Hunter Children's Hospital paediatric diabetes clinic. They were between the ages of 8-18 years old.
Type 1 Diabetes Mellitus
  • Procedure: Video Nailfold Capillaroscopy
    Single session of video Nailfold Capillaroscopy wit KKK technology
  • Device: Ambulatory 24 hr Blood Pressure Monitoring
    24 hr upper arm cuff measurement of Blood Pressure
  • Procedure: Fundoscopy of eyes
    examination of microvascular health of eye with the use of opthalmoscope
  • Procedure: Laser Doppler Flowmetry
    Examination of vascular flow
Type 1 Diabetes Paediatric
Paediatric patients aged 8-18 with diagnosed Diabetes Mellitis Type 1 attending paediatric clinic at John Hunter Hospital.
Interventions:
  • Procedure: Video Nailfold Capillaroscopy
  • Device: Ambulatory 24 hr Blood Pressure Monitoring
  • Procedure: Fundoscopy of eyes
  • Procedure: Laser Doppler Flowmetry
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
October 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 8-18 years old
  • Have a diagnosis of type 1 diabetes mellitus

Exclusion Criteria:

  • < 8 years or > 18 years old
  • Significant autoimmune rheumatological disease (e.g. lupus or dermatomyositis)
Both
8 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01279928
HNEHREC 09/04/15/5.10
No
Associate Professor Glenn Reeves, John Hunter Hospital
John Hunter Hospital
Not Provided
Principal Investigator: Rani Bhatia, MD John Hunter Children's Hospital
John Hunter Hospital
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP