Trial Outcomes & Findings for Dyslipidemia and Diabetic Retinopathy (NCT NCT03403283)
NCT ID: NCT03403283
Last Updated: 2024-05-21
Results Overview
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
Recruitment status
COMPLETED
Target enrollment
45 participants
Primary outcome timeframe
3 years
Results posted on
2024-05-21
Participant Flow
Participant milestones
| Measure |
Group 1
Diabetic
15 subjects with Non Proliferative Diabetic Retinopathy(mild, moderate and severe). 15 subjects with Proliferative Diabetic Retinopathy
|
Group 2
Healthy Controls
Healthy Controls 15 age matched control subjects
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
15
|
|
Overall Study
COMPLETED
|
30
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1
n=30 Participants
Diabetic
15 subjects with Non Proliferative Diabetic Retinopathy(mild, moderate and severe). 15 subjects with Proliferative Diabetic Retinopathy
|
Group 2
n=15 Participants
Healthy Controls
Healthy Controls 15 age matched control subjects
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=30 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=45 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=30 Participants
|
15 Participants
n=15 Participants
|
45 Participants
n=45 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=30 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=45 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=30 Participants
|
10 Participants
n=15 Participants
|
30 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=30 Participants
|
5 Participants
n=15 Participants
|
15 Participants
n=45 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
30 Participants
n=30 Participants
|
15 Participants
n=15 Participants
|
45 Participants
n=45 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPeripheral 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
Outcome measures
| Measure |
Group 1
n=30 Participants
Diabetic
15 subjects with Non Proliferative Diabetic Retinopathy(mild, moderate and severe). 15 subjects with Proliferative Diabetic Retinopathy
|
Group 2
n=15 Participants
Healthy Controls
Healthy Controls 15 age matched control subjects
|
|---|---|---|
|
Increase in Acid Sphingomyelinase (ASM) Expression and Activity in Bone Marrow-derived Endothelial Progenitor Cells (EPCs)
|
0.2 nM/hr
Standard Deviation 0.03
|
0.5 nM/hr
Standard Deviation 0.04
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place