An observational study in Diabetic Retinopathy and Dyslipidemia, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-21.
Sponsored by University of Alabama at Birmingham · Observational
The purpose of this study is to determine if the reparative cells of blood vessels called endothelial progenitor cells(EPC) are defective in people with diabetes.
The purpose of this study is to determine if the reparative cells of blood vessels, called endothelial progenitor cells (EPC's) are defective in people with diabetes. Diabetic retinopathy (DR) is an eye disease related to diabetes. It can cause blurred vision and possible bleeding in the blood vessels in the back of the eye (retina). Damage to the cells of the blood vessels from DR can cause vision loss or blindness. Even with current treatments, the quality of life for people with DR is much reduced.
Ophthalmology and Primary Care Clinics
Exclusion Criteria:
Diabetics with mild, moderate or severe non proliferative retinopathy and proliferative retinopathy
Other: 15 subjects with Non Proliferative Diabetic Retinopathy(mild, moderate and severe). 15 subjects with Proliferative Diabetic Retinopathy
Healthy Controls
Other: Healthy Controls 15 age matched control subjects
Also known as: NPDR - Non Proliferative Diabetic Retinopathy, PDR -Proliferative Diabetic Retinopathy
Increase in Acid Sphingomyelinase (ASM) Expression and Activity in Bone Marrow-derived Endothelial Progenitor Cells (EPCs)
Peripheral blood of 150 cc, about 8-10 tablespoons will be collected from vein in the arm of both diabetic and control subjects.ASM activity was measured on a scale of 0-0.6. 0.6 is worse with units being nM/hr
Time frame: 3 years
| Milestone | Group 1 | Group 2 |
|---|---|---|
| Started | 30 | 15 |
| Completed | 30 | 15 |
| Not completed | 0 | 0 |
Peripheral blood of 150 cc, about 8-10 tablespoons will be collected from vein in the arm of both diabetic and control subjects.ASM activity was measured on a scale of 0-0.6. 0.6 is worse with units being nM/hr
| nM/hr | Group 1 | Group 2 |
|---|---|---|
| Increase in Acid Sphingomyelinase (ASM) Expression and Activity in Bone Marrow-derived Endothelial Progenitor Cells (EPCs) | 0.2 ± 0.03 | 0.5 ± 0.04 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Group 2 | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Age, Categorical(Participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 30 | 15 | 45 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Female | 20 | 10 | 30 |
| Male | 10 | 5 | 15 |
| Race and Ethnicity Not Collected(Participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| United States | 30 | 15 | 45 |
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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham