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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01279928




Registration number
NCT01279928
Ethics application status
Date submitted
19/01/2011
Date registered
20/01/2011
Date last updated
25/01/2011

Titles & IDs
Public title
Detection of Vascular Injury in Diabetes Through Eye and Nailfold Data (DIVIDEND) - A Pilot Study
Scientific title
Detection of Vascular Injury in Diabetes Through Eye and Nailfold Data (DIVIDEND) - A Pilot Study
Secondary ID [1] 0 0
HNEHREC 09/04/15/5.10
Universal Trial Number (UTN)
Trial acronym
DIVIDEND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes Mellitus 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Video Nailfold Capillaroscopy
Treatment: Devices - Ambulatory 24 hr Blood Pressure Monitoring
Treatment: Surgery - Fundoscopy of eyes
Treatment: Surgery - Laser Doppler Flowmetry

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


Treatment: Surgery: Video Nailfold Capillaroscopy
Single session of video Nailfold Capillaroscopy wit KKK technology

Treatment: Devices: Ambulatory 24 hr Blood Pressure Monitoring
24 hr upper arm cuff measurement of Blood Pressure

Treatment: Surgery: Fundoscopy of eyes
examination of microvascular health of eye with the use of opthalmoscope

Treatment: Surgery: Laser Doppler Flowmetry
Examination of vascular flow
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
- 8-18 years old

- Have a diagnosis of type 1 diabetes mellitus
Minimum age
8 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- < 8 years or > 18 years old

- Significant autoimmune rheumatological disease (e.g. lupus or dermatomyositis)

Study design
Purpose
Duration
Cross-sectional
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2010
Sample size
Target
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
John Hunter Children's Hospital - New Lambton
Recruitment postcode(s) [1] 0 0
2305 - New Lambton

Funding & Sponsors
Primary sponsor type
Other
Name
John Hunter Hospital
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01279928
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rani Bhatia, MD
Address 0 0
John Hunter Children's Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01279928