Diabetic Retinopathy and Sickle Trait
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Purpose
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.
| Condition |
|---|
|
Diabetic Retinopathy Sickle Cell Trait |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Diabetic Retinopathy and Sickle Cell Trait |
- 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 ]
| Enrollment: | 48 |
| Study Start Date: | May 2008 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
African-Americans with type II diabetes mellitus experience increased systemic vascular morbidity and mortality, even after adjustment for socioeconomic factors.
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
Contacts and Locations| United States, South Carolina | |
| Medical University of South Carolina, Storm Eye Institute | |
| Charleston, South Carolina, United States, 29425 | |
| Principal Investigator: | Esther M. Bowie, MD | Medical University of South Carolina, Storm Eye Institute |
More Information
No publications provided
| Responsible Party: | Esther M. Bowie, MD, Medical University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT00720317 History of Changes |
| Other Study ID Numbers: | SEI-08-001 |
| Study First Received: | July 18, 2008 |
| Last Updated: | September 15, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Medical University of South Carolina:
|
Diabetic Retinopathy Sickle Cell Trait Vision Loss Eye disease |
Additional relevant MeSH terms:
|
Diabetic Retinopathy Retinal Diseases Sickle Cell Trait Eye Diseases Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus |
Endocrine System Diseases Anemia, Sickle Cell Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn |
ClinicalTrials.gov processed this record on May 16, 2013