An observational study in Diabetic Retinopathy and Sickle Cell Trait, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2010-09-16.
Sponsored by Medical University of South Carolina · Observational
To more clearly ascertain the relationship between ocular manifestations of sickle cell disease and diabetes, specifically; whether the presence of sickle cell trait exacerbates the disease progression of diabetic retinopathy.
The objective of this research study is to evaluate the relationship between sickle cell trait and the progression of diabetic retinopathy. People with diabetes have high blood sugar that damages small blood vessels. Damage to the blood vessels that supply the retina in the back of the eye is called diabetic retinopathy. Diabetic retinopathy is worse in African-Americans with diabetes, with earlier and more severe disease progression and common complications including vitreous hemorrhage - where these blood vessels in the eye leak - and retinal detachment - the separation of the nerves of the retina from the back of the eye which may lead to blindness. One explanation for this increased severity of diabetes in African-Americans is the presence of sickle cell disease, or even just sickle trait, which causes damage to red blood cells and blood vessels under conditions of stress; like low oxygen levels, or hyperglycemic acidosis.
778 studies on the registry are indexed under Diabetic Retinopathy; 142 are open to participants now.
This study's enrollment of 48 is below the median of 172 across 263 observational studies indexed under Diabetic Retinopathy.
Browse Diabetic Retinopathy studies →Medical University of South Carolina is the lead sponsor of 874 studies on the registry; 166 are open to participants now.
Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.
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African-Americans with type II diabetes mellitus experience increased systemic vascular morbidity and mortality, even after adjustment for socioeconomic factors.
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Exclusion Criteria:
We aim to screen African-American diabetic patients with retinopathy to ascertain whether sickle trait is present, and if so whether there is increased severity of diabetic retinopathy in the group with sickle trait.
Time frame: One Year
The record gives a start of May 2008, a primary completion of Jul 2010 and a completion of Jul 2010. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.
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Medical University of South Carolina →