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Completed

NCT Number: NCT01785667

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Retinal Diseases Vascular Diseases

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Ophthalmology, Odense University Hospital

Odense, Fyn, 5000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participation in the follow-up study in 1995

Exclusion criteria

  • No retinal photographs from 1995

Treatment and study plan

Primary outcomes

  1. 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

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

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

Registry information

Acronym: DCPD1987

Important dates

Study start
2011
Primary completion
2011
Study completion
2013
First posted
Feb 7, 2013
Registry last updated
Jul 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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