Diabetes Mellitus Clinical Trial
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.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | June 2010 |
| Est. primary completion date | June 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 60 Years |
| Eligibility |
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. |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Glostrup Hospital | Glostrup |
| Lead Sponsor | Collaborator |
|---|---|
| Glostrup University Hospital, Copenhagen |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes in amplitude/implicit times, retinal vessel diameter, dark adaptation and OCT | 1 week, 1 month, 4 months, 1 year | No |
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