Clincosm LogoSign in Get a demo

DCPD1987: Incidence of Retinopathy and Associated Risk Factors in Children and Young Adults With Type 1 Diabetes in Denmark

Sponsor
Odense University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01785667
Collaborator
Center for Eye Research Australia (Other), Moorfields Eye Hospital NHS Foundation Trust (Other)
132
Enrollment
1
Location
25
Duration (Months)
5.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to clarify the current diabetic status, including development of complications, in a nationwide cohort of type 1 diabetics, who were last examined together in a large study in 1995. These youngsters were originally participating in a nationwide study of children with type 1 diabetes in Denmark back in 1986. The investigators will try to establish risk factors for developing diabetic retinopathy. The investigators will have emphasis on retinal vessel geometry and the possibilities for early detection of reversible retinal changes, and prediction of other vascular complications.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    132 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Incidence of Retinopathy and Associated Risk Factors in Children and Young Adults With Type 1 Diabetes in Denmark
    Study Start Date :
    Jan 1, 2011
    Actual Primary Completion Date :
    Nov 1, 2011
    Actual Study Completion Date :
    Feb 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Young Danish adults with type 1 diabetes

    This is an observational study with no interventions.

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of diabetic retinopathy and proliferative diabetic retinopathy [16 years]

      Using the ETDRS grading protocol the degree of retinopathy in 2011 will be assessed by grading 7-field fundus photographs taken at follow-up examination. This will be related to the degree of retinopathy found in the patients in 1995, where the last study of the cohort took place.

    Secondary Outcome Measures

    1. Vessel diameters as a predictor of diabetic retinopathy and proliferative diabetic retinopathy [16 years]

      Using the computer software named IVAN we will assess the average vessel diameters around the optic disc on fundus photos from 1995. This we will relate to the degree of retinopathy in 2011 to see if vessel diameters predicts diabetic eye complications.

    Other Outcome Measures

    1. Fractal dimensions as a predictor of diabetic retinopathy and proliferative diabetic retinopathy [16 years]

      Using the computer software named Fractal Analyzer we will assess the fractal dimension around the optic disc on fundus photos from 1995. This we will relate to the degree of retinopathy in 2011 to see if fractals can help predict diabetic eye complications.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Participation in the follow-up study in 1995
    Exclusion Criteria:
    • No retinal photographs from 1995

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Ophthalmology, Odense University Hospital Odense Fyn Denmark 5000

    Sponsors and Collaborators

    • Odense University Hospital
    • Center for Eye Research Australia
    • Moorfields Eye Hospital NHS Foundation Trust

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rebecca Broe Pedersen, MD, Odense University Hospital
    ClinicalTrials.gov Identifier:
    NCT01785667
    Other Study ID Numbers:
    • S-20100088
    First Posted:
    Feb 7, 2013
    Last Update Posted:
    Jul 30, 2014
    Last Verified:
    Jul 1, 2014
    Additional relevant MeSH terms:
    Retinal Diseases
    Diabetic Retinopathy
    Diabetes Mellitus
    Diabetes Mellitus, Type 1

    Study Results

    No Results Posted as of Jul 30, 2014