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

NCT01785667 | Completed

• 1 other identifier: S-20100088
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes; Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Vessel diameters as a predictor of diabetic retinopathy and proliferative diabetic retinopathy

  16 years

Other Outcomes (1)

• Fractal dimensions as a predictor of diabetic retinopathy and proliferative diabetic retinopathy

  16 years

Study Arms (1)

Young Danish adults with type 1 diabetes

This is an observational study with no interventions.

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Participation in the follow-up study in 1995

You may not qualify if:

• No retinal photographs from 1995

Sponsors & Collaborators

• Odense University Hospital: lead
• Center for Eye Research Australia: collaborator
• Moorfields Eye Hospital NHS Foundation Trust: collaborator

Study Sites (1)

Department of Ophthalmology, Odense University Hospital

Odense, Fyn, 5000, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

buffy coat, whole blood, urine

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetic Retinopathy

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 16 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 5, 2013
• First Posted: February 7, 2013
• Study Start: January 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: February 1, 2013
• Last Updated: July 30, 2014

Record last verified: 2014-07

Locations

DK (1)