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

Completed

• Conditions: Diabetic Retinopathy; Type 1 Diabetes

• Registration Number: NCT01785667
• Lead Sponsor: Odense University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-11
• Study Completion: 2013-02
• Study First Submitted: 2013-02-05
• Study First Submitted QC: 2013-02-06
• Study First Posted: 2013-02-07
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-29
• Last Update Posted: 2014-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• Participation in the follow-up study in 1995

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Exclusion Criteria

• No retinal photographs from 1995

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Ophthalmology, Odense University Hospital; 🇩🇰 Odense, Fyn, Denmark