Trial Outcomes & Findings for Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects (NCT NCT02422446)
NCT ID: NCT02422446
Last Updated: 2022-03-18
Results Overview
Digital pulse amplitude will be measured with a fingertip peripheral arterial tonometry (PAT) device (Endo-PAT2000, Itamar Medical) in a supine position. Baseline pulse amplitude will be measured for 5 minutes, then the arterial flow will then be interrupted for 5 minutes with a cuff placed on a proximal forearm. Pulse amplitude will be recorded electronically and analyzed by a computerized and automated algorithm. The change from the baseline measurement will be expressed as the reactive hyperemia index (RHI). We will calculate the pulse amplitude response to hyperemia for each 30-second interval as a ratio of the post-deflation pulse amplitude to the baseline pulse amplitude as described previously. The RHI ratio will be computed by dividing the ratio obtained on the test side over the ratio from the control finger. We will assess change in RHI ratio between baseline value and 12-week value after the intervention.
TERMINATED
PHASE3
2 participants
Between baseline and 12 weeks
2022-03-18
Participant Flow
Participant milestones
| Measure |
EPA Arm
EPA arm will receive 4 grams per day of EPA (icosapent ethyl) taken twice a day
Icosapent ethyl: icosapent ethyl is eicosapentaenoic acid, an omega-3 fatty acid that naturally occurs in fish
|
Control
Control group will not receive EPA
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects
Baseline characteristics by cohort
| Measure |
EPA Arm
n=1 Participants
EPA arm will receive 4 grams per day of EPA (icosapent ethyl) taken twice a day
Icosapent ethyl: icosapent ethyl is eicosapentaenoic acid, an omega-3 fatty acid that naturally occurs in fish
|
Control
n=1 Participants
Control group will not receive EPA
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69 years
n=99 Participants
|
57 years
n=107 Participants
|
63 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Triglycerides
|
221 mg/dl
n=99 Participants
|
177 mg/dl
n=107 Participants
|
199 mg/dl
n=206 Participants
|
PRIMARY outcome
Timeframe: Between baseline and 12 weeksDigital pulse amplitude will be measured with a fingertip peripheral arterial tonometry (PAT) device (Endo-PAT2000, Itamar Medical) in a supine position. Baseline pulse amplitude will be measured for 5 minutes, then the arterial flow will then be interrupted for 5 minutes with a cuff placed on a proximal forearm. Pulse amplitude will be recorded electronically and analyzed by a computerized and automated algorithm. The change from the baseline measurement will be expressed as the reactive hyperemia index (RHI). We will calculate the pulse amplitude response to hyperemia for each 30-second interval as a ratio of the post-deflation pulse amplitude to the baseline pulse amplitude as described previously. The RHI ratio will be computed by dividing the ratio obtained on the test side over the ratio from the control finger. We will assess change in RHI ratio between baseline value and 12-week value after the intervention.
Outcome measures
| Measure |
EPA Arm
n=1 Participants
EPA arm will receive 4 grams per day of EPA (icosapent ethyl) taken twice a day
Icosapent ethyl: icosapent ethyl is eicosapentaenoic acid, an omega-3 fatty acid that naturally occurs in fish
|
Control
n=1 Participants
Control group will not receive EPA
|
|---|---|---|
|
Change From Baseline in Endothelial Function at 12 Weeks Using Reactive Hyperemia Index (RHI)
|
-29 % change from baseline value
Interval -29.0 to -29.0
|
-1.6 % change from baseline value
Interval -1.6 to -1.6
|
SECONDARY outcome
Timeframe: change between baseline and 12 weeks post-interventionPopulation: Because the trial was terminated prematurely due to difficulties in finding suitable subjects, we were not able to measure any of the three biomarkers specified under the secondary outcome (ET-1, hsCRP, and Oxidized LDL).
Plasma hsCRP will be measured by Sandwich enzyme linked immunosorbent assay (ELISA). Plasma oxidized LDL and plasma ET-1 will be measured using a commercially available sandwich-enzyme immunoassay kit (R \& D).
Outcome measures
Outcome data not reported
Adverse Events
EPA Arm
Control
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