Diabetic Retinopathy and Sickle Trait

Diabetic Retinopathy Clinical Trial

Official title:

Diabetic Retinopathy and Sickle Cell Trait

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00720317
• Other study ID #: SEI-08-001
• Status: Completed
• Phase: N/A
• First received: July 18, 2008
• Last updated: September 15, 2010
• Start date: May 2008
• Est. completion date: July 2010

Study information

• Verified date: September 2010
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases
• Sickle Cell Trait

Locations

Country	Name	City	State
United States	Medical University of South Carolina, Storm Eye Institute	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		One Year	No