Retinal Function in Relation to Long Term Changes in the Glucose Level

• Conditions: Diabetes Mellitus

• Registration Number: NCT00973401
• Lead Sponsor: Glostrup University Hospital, Copenhagen

Brief Summary

The purpose of this study is to measure the amplitude and implicit time of electroretinogram (ERG), darkadaptation and the calibre of retinal vessels before and after optimized medical treatment of diabetic individuals (a lower blood glucose level) over a period of 12 months. Newly diagnosed type 1 and type 2 diabetics as well as dysregulated type 1 and type 2 diabetic individuals will be included. Retinal vessel calibre measurements will be used as an estimation of changes in the retinal perfusion.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-09
• Study Start: 2009-09
• Study First Submitted: 2009-09-08
• Study First Submitted QC: 2009-09-08
• Study First Posted: 2009-09-09
• Last Update Submitted: 2009-09-23
• Last Update Posted: 2009-09-24
• Primary Completion: 2010-06
• Study Completion: 2010-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Dysregulated type 1 diabetic individuals and newly diagnosed type 1 diabetics. Age >17 < 60 years

Exclusion Criteria

• Test individuals with significant cataract, prior surgery to the eye, diabetic retinopathy, other serious eye disease, hypertension, other serious systemic disease.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in amplitude/implicit times, retinal vessel diameter, dark adaptation and OCT	1 week, 1 month, 4 months, 1 year

Trial Locations

Locations (1)

Glostrup Hospital; 🇩🇰 Glostrup, Denmark