Diabetic Retinopathy
Conditions
Keywords
Diabetes, Retinopathy
Brief summary
The purpose of this research study is to study blood stem cells in diabetic patients and normal patients. We would like to better understand if these cells, called endothelial precursor cells (EPCs), are not working as expected in people with diabetes. We would like to see if the function of these cells can predict the development of diabetic retinopathy. Diabetic retinopathy is an eye disease associated with diabetes in which the cells of the retina are damaged. It can cause blurred vision, vision loss, blindness or possible bleeding in the retina. Even with current treatments, the quality of life for people with diabetic retinopathy is much reduced.
Interventions
OTHERDiabetic Patients
measuring CD34 cell function in relation to diabetic retinopathy status
OTHERHealthy Controls
measuring CD34 cell function
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Alabama at Birmingham
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Men or women 18 years or older * 39 type 1 or type 2 diabetic patients * 13 with mild retinopathy * 13 with moderate retinopathy * 13 with severe, nonproliferative retinopathy * 39 age and sex matched healthy controls
Exclusion criteria
* Current pregnancy as evidence by a urine pregnancy test as the blood from a pregnant female will influence the results of the laboratory tests
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The ACE/ACE2 ratio within EPC's | up to 216 weeks | Peripheral blood of 150cc, approximately 8-10 tablespoons will be collected from a vein in the arm of both diabetic and healthy control patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The balance of the RAS (renin-angiotensin system) within EPCs | up to 216 weeks | The Endo-PAT2000 will be used to obtain this measurement. This is a 15-minute office-based test where a blood-pressure cuff is placed around the arm, inflated and measurements are obtained from a small fingertip monitor |
Other
| Measure | Time frame | Description |
|---|---|---|
| Photography findings | up to 216 weeks | The findings from eye photographs will be collected and evaluated from both the diabetic patients and the heallthy control patients. This will be done at either the patient's yearly visit or at their 6 week follow-up visit. |
| Fluorescein angiogram findings | up to 216 weeks | The findings from eye photographs will be collected and evaluated from both the diabetic patients and the heallthy control patients. This will be done at either the patient's yearly visit or at their 6 week follow-up visit. |
Countries
United States
Outcome results
None listed