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

Type 1 Diabetes Mellitus Clinical Trial

— DIVIDEND  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01279928
• Other study ID #: HNEHREC 09/04/15/5.10
• Status: Completed
• Phase: N/A
• First received: January 19, 2011
• Last updated: January 24, 2011
• Start date: March 2010
• Est. completion date: October 2010

Study information

• Verified date: January 2011
• Source: John Hunter Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Therapeutic Goods Administration
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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)

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus
• Vascular System Injuries

Intervention

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
• Laser Doppler Flowmetry
Examination of vascular flow

Locations

Country	Name	City	State
Australia	John Hunter Children's Hospital	New Lambton	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
John Hunter Hospital

Country where clinical trial is conducted

Australia,