N/A
N=45
Dyslipidemia and Diabetic Retinopathy
Diabetic Retinopathy · Dyslipidemia
Bottom Line
View on ClinicalTrials.gov: NCT03403283 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Increase in Acid Sphingomyelinase (ASM) Expression and Activity in Bone Marrow-derived Endothelial Progenitor Cells (EPCs) — 0.2; 0.5 nM/hr
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- 15 subjects with Non Proliferative Diabetic Retinopathy(mild, moderate and severe). 15 subjects with Proliferative Diabetic Retinopathy (Other); Healthy Controls 15 age matched control subjects (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Increase in Acid Sphingomyelinase (ASM) Expression and Activity in Bone Marrow-derived Endothelial Progenitor Cells (EPCs) |
0.2; 0.5 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03403283). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.