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
  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

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • 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)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00720317

Locations
United States, South Carolina
Medical University of South Carolina, Storm Eye Institute
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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 July 29, 2014