Diabetic Retinopathy and Sickle Trait

This study has been completed.
Sponsor:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00720317
First received: July 18, 2008
Last updated: September 15, 2010
Last verified: September 2010

July 18, 2008
September 15, 2010
May 2008
July 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00720317 on ClinicalTrials.gov Archive Site
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Diabetic Retinopathy and Sickle Trait
Diabetic Retinopathy and Sickle Cell Trait

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

African-Americans with type II diabetes mellitus experience increased systemic vascular morbidity and mortality, even after adjustment for socioeconomic factors.

  • Diabetic Retinopathy
  • Sickle Cell Trait
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Self-identified African-American patients with diabetes will be identified from Dr Bowie's retina clinic at Storm Eye Institute.
  • These subjects are either being screened or treated for the progression of diabetic retinopathy.

Exclusion Criteria:

  • None
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00720317
SEI-08-001
No
Esther M. Bowie, MD, Medical University of South Carolina
Medical University of South Carolina
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Principal Investigator: Esther M. Bowie, MD Medical University of South Carolina, Storm Eye Institute
Medical University of South Carolina
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP