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Clinical Trials/NCT01785667
NCT01785667CompletedNot Applicable

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

Odense University Hospital1 site in 1 country132 target enrollmentStarted: January 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
132
Locations
1
Primary Endpoint
Incidence of diabetic retinopathy and proliferative diabetic retinopathy

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
25 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participation in the follow-up study in 1995

Exclusion Criteria

  • No retinal photographs from 1995

Outcomes

Primary Outcomes

Incidence of diabetic retinopathy and proliferative diabetic retinopathy

Time Frame: 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 Outcomes

  • Vessel diameters as a predictor of diabetic retinopathy and proliferative diabetic retinopathy(16 years)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rebecca Broe Pedersen

MD

Odense University Hospital

Study Sites (1)

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