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

NCT ID: NCT01279928

Last Updated: 2011-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-10-31

Brief Summary

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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

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Conditions

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Type 1 Diabetes Mellitus

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Type 1 Diabetes Paediatric

Paediatric patients aged 8-18 with diagnosed Diabetes Mellitis Type 1 attending paediatric clinic at John Hunter Hospital.

Video Nailfold Capillaroscopy

Intervention Type PROCEDURE

Single session of video Nailfold Capillaroscopy wit KKK technology

Ambulatory 24 hr Blood Pressure Monitoring

Intervention Type DEVICE

24 hr upper arm cuff measurement of Blood Pressure

Fundoscopy of eyes

Intervention Type PROCEDURE

examination of microvascular health of eye with the use of opthalmoscope

Laser Doppler Flowmetry

Intervention Type PROCEDURE

Examination of vascular flow

Interventions

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Video Nailfold Capillaroscopy

Single session of video Nailfold Capillaroscopy wit KKK technology

Intervention Type PROCEDURE

Ambulatory 24 hr Blood Pressure Monitoring

24 hr upper arm cuff measurement of Blood Pressure

Intervention Type DEVICE

Fundoscopy of eyes

examination of microvascular health of eye with the use of opthalmoscope

Intervention Type PROCEDURE

Laser Doppler Flowmetry

Examination of vascular flow

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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John Hunter Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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John Hunter Hospital

Principal Investigators

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Rani Bhatia, MD

Role: PRINCIPAL_INVESTIGATOR

John Hunter Children's Hospital

Locations

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John Hunter Children's Hospital

New Lambton, New South Wales, Australia

Site Status

Countries

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Australia

References

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Hosking SP, Bhatia R, Crock PA, Wright I, Squance ML, Reeves G. Non-invasive detection of microvascular changes in a paediatric and adolescent population with type 1 diabetes: a pilot cross-sectional study. BMC Endocr Disord. 2013 Oct 5;13:41. doi: 10.1186/1472-6823-13-41.

Reference Type DERIVED
PMID: 24093770 (View on PubMed)

Other Identifiers

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HNEHREC 09/04/15/5.10

Identifier Type: -

Identifier Source: org_study_id

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