Diabetic Retinopathy, Dyslipidemia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHER15 subjects with Non Proliferative Diabetic Retinopathy(mild, moderate and severe). 15 subjects with Proliferative Diabetic Retinopathy
OTHERHealthy Controls 15 age matched control subjects
Sponsors
National Eye Institute (NEI)
University of Alabama at Birmingham
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Any man or woman * Greater than 18 years of age * Diagnosis of diabetes (applies to the Diabetic Arm only) (N=15 Type 1 and N=15 Type * The subject must be willing and have the ability to cooperate with the protocol. Children will not be eligible because the investigators need to obtain 150 ml of blood and this is in excess of what can be drawn in children.
Exclusion criteria
* Female participants must not be pregnant at the time of the blood draw as evident through a dipstick pregnancy test. * Have retinal abnormalities other than diabetic retinopathy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Increase in Acid Sphingomyelinase (ASM) Expression and Activity in Bone Marrow-derived Endothelial Progenitor Cells (EPCs) | 3 years | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Diabetic
15 subjects with Non Proliferative Diabetic Retinopathy(mild, moderate and severe). 15 subjects with Proliferative Diabetic Retinopathy | 30 |
| Group 2 Healthy Controls
Healthy Controls 15 age matched control subjects | 15 |
| Total | 45 |
Baseline characteristics
| Characteristic | Group 2 | Total | Group 1 |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 45 Participants | 30 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 15 Participants | 45 Participants | 30 Participants |
| Sex: Female, Male Female | 10 Participants | 30 Participants | 20 Participants |
| Sex: Female, Male Male | 5 Participants | 15 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 15 |
| other Total, other adverse events | 0 / 30 | 0 / 15 |
| serious Total, serious adverse events | 0 / 30 | 0 / 15 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Increase in Acid Sphingomyelinase (ASM) Expression and Activity in Bone Marrow-derived Endothelial Progenitor Cells (EPCs) | 0.2 nM/hr | Standard Deviation 0.03 |
| Group 2 | Increase in Acid Sphingomyelinase (ASM) Expression and Activity in Bone Marrow-derived Endothelial Progenitor Cells (EPCs) | 0.5 nM/hr | Standard Deviation 0.04 |