ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01785667
Recruitment Status : Completed
First Posted : February 7, 2013
Last Update Posted : July 30, 2014
Sponsor:
Collaborators:
Center for Eye Research Australia
Moorfields Eye Hospital NHS Foundation Trust
Information provided by (Responsible Party):
Rebecca Broe Pedersen, 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.

Condition or disease
Type 1 Diabetes Diabetic Retinopathy

Study Type : Observational [Patient Registry]
Actual Enrollment : 132 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 16 Years
Official Title: Incidence of Retinopathy and Associated Risk Factors in Children and Young Adults With Type 1 Diabetes in Denmark
Study Start Date : January 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Biospecimen Retention:   Samples With DNA
buffy coat, whole blood, urine


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • Participation in the follow-up study in 1995

Exclusion Criteria:

  • No retinal photographs from 1995

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785667


Locations
Denmark
Department of Ophthalmology, Odense University Hospital
Odense, Fyn, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Center for Eye Research Australia
Moorfields Eye Hospital NHS Foundation Trust

Responsible Party: Rebecca Broe Pedersen, MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01785667     History of Changes
Other Study ID Numbers: S-20100088
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: July 30, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Retinal Diseases
Diabetic Retinopathy
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications