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

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Procedure: Video Nailfold Capillaroscopy; Device: Ambulatory 24 hr Blood Pressure Monitoring; Procedure: Fundoscopy of eyes; Procedure: Laser Doppler Flowmetry

• Registration Number: NCT01279928
• Lead Sponsor: John Hunter Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2010-09
• Study Completion: 2010-10
• Status Verified: 2011-01
• Study First Submitted: 2011-01-19
• Study First Submitted QC: 2011-01-19
• Study First Posted: 2011-01-20
• Last Update Submitted: 2011-01-24
• Last Update Posted: 2011-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Type 1 Diabetes Paediatric	Fundoscopy of eyes	Paediatric patients aged 8-18 with diagnosed Diabetes Mellitis Type 1 attending paediatric clinic at John Hunter Hospital.
Type 1 Diabetes Paediatric	Video Nailfold Capillaroscopy	Paediatric patients aged 8-18 with diagnosed Diabetes Mellitis Type 1 attending paediatric clinic at John Hunter Hospital.
Type 1 Diabetes Paediatric	Ambulatory 24 hr Blood Pressure Monitoring	Paediatric patients aged 8-18 with diagnosed Diabetes Mellitis Type 1 attending paediatric clinic at John Hunter Hospital.
Type 1 Diabetes Paediatric	Laser Doppler Flowmetry	Paediatric patients aged 8-18 with diagnosed Diabetes Mellitis Type 1 attending paediatric clinic at John Hunter Hospital.

Trial Locations

Locations (1)

John Hunter Children's Hospital; 🇦🇺 New Lambton, New South Wales, Australia