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

Type 1 Diabetes Clinical Trial

— DCPD1987  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01785667
• Other study ID #: S-20100088
• Status: Completed
• Phase: N/A
• First received: February 5, 2013
• Last updated: July 29, 2014
• Start date: January 2011
• Est. completion date: February 2013

Study information

• Verified date: July 2014
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: February 2013
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

• Participation in the follow-up study in 1995

Exclusion Criteria:

• No retinal photographs from 1995

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Diabetic Retinopathy
• Retinal Diseases
• Type 1 Diabetes

Locations

Country	Name	City	State
Denmark	Department of Ophthalmology, Odense University Hospital	Odense	Fyn

Sponsors (3)

Lead Sponsor	Collaborator
Odense University Hospital	Center for Eye Research Australia, Moorfields Eye Hospital NHS Foundation Trust

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fractal dimensions as a predictor of diabetic retinopathy and proliferative diabetic retinopathy	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.	16 years	No
Primary	Incidence of diabetic retinopathy and proliferative diabetic retinopathy	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.	16 years	No
Secondary	Vessel diameters as a predictor of diabetic retinopathy and proliferative diabetic retinopathy	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.	16 years	No