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Completed

NCT Number: NCT01279928

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.

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Key information

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

John Hunter Children's Hospital

New Lambton, New South Wales, 2305, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Video Nailfold Capillaroscopy

Procedure

Single session of video Nailfold Capillaroscopy wit KKK technology

Ambulatory 24 hr Blood Pressure Monitoring

Device

24 hr upper arm cuff measurement of Blood Pressure

Fundoscopy of eyes

Procedure

examination of microvascular health of eye with the use of opthalmoscope

Laser Doppler Flowmetry

Procedure

Examination of vascular flow

Sponsors and collaborators

Lead sponsor

John Hunter Hospital

Other Gov

Registry information

Acronym: DIVIDEND

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 20, 2011
Registry last updated
Jan 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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