| Trial ID: | L5893 |
| Source ID: | NCT02422446
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| Associated Drug: |
Icosapent Ethyl
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| Title: |
Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects
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| Acronym: |
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| Status: |
TERMINATED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT02422446/results
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| Conditions: |
Type 2 Diabetes|Coronary Artery Disease
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| Interventions: |
DRUG: Icosapent ethyl
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| Outcome Measures: |
Primary: Change From Baseline in Endothelial Function at 12 Weeks Using Reactive Hyperemia Index (RHI), 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., Between baseline and 12 weeks | Secondary: Change in Endothelin-1 (ET-1), High-sensitive C-reactive Protein (hsCRP), and Oxidized LDL Between Baseline and 12 Weeks, 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)., change between baseline and 12 weeks post-intervention
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| Sponsor/Collaborators: |
Sponsor: Brigham and Women's Hospital
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE3
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| Enrollment: |
2
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: PREVENTION
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| Start Date: |
2015-04
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| Completion Date: |
2017-03-01
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| Results First Posted: |
2018-06-06
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| Last Update Posted: |
2022-03-18
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| Locations: |
Brigham and Women's Hospital, Boston, Massachusetts, 02120, United States
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| URL: |
https://clinicaltrials.gov/show/NCT02422446
|
