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

July 29, 2014 updated by: Rebecca Broe Pedersen, Odense University Hospital
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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

132

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Fyn
      • Odense, Fyn, Denmark, 5000
        • Department of Ophthalmology, Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This study includes a cohort of type 1 diabetic patients, who originally were identified in 21 paediatric departments and studied in 1986. This group initially consisted of 1033 children and was estimated to involve around 80 percent of all Danish type 1 diabetic patients below the age of 18. In 1995 further examinations were performed on the cohort; this time 339 chose to participate.

In this study we will invite the participants from 1995 who also participated in the eye examinations, n=324, to participate in yet another follow-up examination.

Description

Inclusion Criteria:

  • Participation in the follow-up study in 1995

Exclusion Criteria:

  • No retinal photographs from 1995

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Young Danish adults with type 1 diabetes
This is an observational study with no interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
16 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vessel diameters as a predictor of diabetic retinopathy and proliferative diabetic retinopathy
Time Frame: 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.
16 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fractal dimensions as a predictor of diabetic retinopathy and proliferative diabetic retinopathy
Time Frame: 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.
16 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Collaborators

Moorfields Eye Hospital NHS Foundation Trust
Center for Eye Research Australia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

February 5, 2013

First Submitted That Met QC Criteria

February 6, 2013

First Posted (Estimate)

February 7, 2013

Study Record Updates

Last Update Posted (Estimate)

July 30, 2014

Last Update Submitted That Met QC Criteria

July 29, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-20100088

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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