NCT01279928

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 20, 2011

Completed
Last Updated

January 25, 2011

Status Verified

January 1, 2011

Enrollment Period

6 months

First QC Date

January 19, 2011

Last Update Submit

January 24, 2011

Conditions

Keywords

paediatric and adolescent populationnailfold capillaroscopylaser Doppler flowmetryretinal vessel calibreretinal vessel fractal analysis24 hour Ambulatory Blood Pressure Monitoring

Study Arms (1)

Type 1 Diabetes Paediatric

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

Procedure: Video Nailfold CapillaroscopyDevice: Ambulatory 24 hr Blood Pressure MonitoringProcedure: Fundoscopy of eyesProcedure: Laser Doppler Flowmetry

Interventions

Single session of video Nailfold Capillaroscopy wit KKK technology

Type 1 Diabetes Paediatric

24 hr upper arm cuff measurement of Blood Pressure

Type 1 Diabetes Paediatric

examination of microvascular health of eye with the use of opthalmoscope

Type 1 Diabetes Paediatric

Examination of vascular flow

Type 1 Diabetes Paediatric

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants were recruited from the John Hunter Children's Hospital paediatric diabetes clinic. They were between the ages of 8-18 years old.

You may qualify if:

  • years old
  • Have a diagnosis of type 1 diabetes mellitus

You may not qualify if:

  • \< 8 years or \> 18 years old
  • Significant autoimmune rheumatological disease (e.g. lupus or dermatomyositis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John Hunter Children's Hospital

New Lambton, New South Wales, 2305, Australia

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Blood Pressure MonitorsLaser-Doppler Flowmetry

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

SphygmomanometersDiagnostic EquipmentEquipment and SuppliesDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRheologyInvestigative Techniques

Study Officials

  • Rani Bhatia, MD

    John Hunter Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 19, 2011

First Posted

January 20, 2011

Study Start

March 1, 2010

Primary Completion

September 1, 2010

Study Completion

October 1, 2010

Last Updated

January 25, 2011

Record last verified: 2011-01

Locations