Detection of Vascular Injury in Diabetes Through Eye and Nailfold Data (DIVIDEND) - A Pilot Study
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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 |
| 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 |
Participants were recruited from the John Hunter Children's Hospital paediatric diabetes clinic. They were between the ages of 8-18 years old.
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| Australia, New South Wales | |
| John Hunter Children's Hospital | |
| New Lambton, New South Wales, Australia, 2305 | |
| 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 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Autoimmune Diseases Immune System Diseases Vascular Diseases Cardiovascular Diseases Wounds and Injuries |
ClinicalTrials.gov processed this record on May 23, 2013