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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
  Purpose

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.


Condition Intervention
Type 1 Diabetes Mellitus
Procedure: Video Nailfold Capillaroscopy
Device: Ambulatory 24 hr Blood Pressure Monitoring
Procedure: Fundoscopy of eyes
Procedure: Laser Doppler Flowmetry

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Detection of Vascular Injury in Diabetes Through Eye and Nailfold Data (DIVIDEND) - A Pilot Study

Resource links provided by NLM:


Further study details as provided by John Hunter Hospital:

Enrollment: 26
Study Start Date: March 2010
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Type 1 Diabetes Paediatric
Paediatric patients aged 8-18 with diagnosed Diabetes Mellitis Type 1 attending paediatric clinic at John Hunter Hospital.
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

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants were recruited from the John Hunter Children's Hospital paediatric diabetes clinic. They were between the ages of 8-18 years old.

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01279928

Locations
Australia, New South Wales
John Hunter Children's Hospital
New Lambton, New South Wales, Australia, 2305
Sponsors and Collaborators
John Hunter Hospital
Investigators
Principal Investigator: Rani Bhatia, MD John Hunter Children's Hospital
  More Information

No publications provided

Responsible Party: Associate Professor Glenn Reeves, John Hunter Hospital
ClinicalTrials.gov Identifier: NCT01279928     History of Changes
Other Study ID Numbers: HNEHREC 09/04/15/5.10
Study First Received: January 19, 2011
Last Updated: January 24, 2011
Health Authority: Australia: Therapeutic Goods Administration

Keywords provided by John Hunter Hospital:
paediatric and adolescent population
nailfold capillaroscopy
laser Doppler flowmetry
retinal vessel calibre
retinal vessel fractal analysis
24 hour Ambulatory Blood Pressure Monitoring

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Vascular System Injuries
Autoimmune Diseases
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Vascular Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014