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Diabetic Retinopathy and Sickle Trait

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00720317
Recruitment Status : Completed
First Posted : July 22, 2008
Last Update Posted : September 16, 2010
Sponsor:
Information provided by:
Medical University of South Carolina

Tracking Information
First Submitted Date July 18, 2008
First Posted Date July 22, 2008
Last Update Posted Date September 16, 2010
Study Start Date May 2008
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 21, 2008)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Diabetic Retinopathy and Sickle Trait
Official Title Diabetic Retinopathy and Sickle Cell Trait
Brief Summary 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.
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population African-Americans with type II diabetes mellitus experience increased systemic vascular morbidity and mortality, even after adjustment for socioeconomic factors.
Condition
  • Diabetic Retinopathy
  • Sickle Cell Trait
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 13, 2010)
48
Original Estimated Enrollment
 (submitted: July 21, 2008)
100
Actual Study Completion Date July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00720317
Other Study ID Numbers SEI-08-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Esther M. Bowie, MD, Medical University of South Carolina
Study Sponsor Medical University of South Carolina
Collaborators Not Provided
Investigators
Principal Investigator: Esther M. Bowie, MD Medical University of South Carolina, Storm Eye Institute
PRS Account Medical University of South Carolina
Verification Date September 2010