Peripheral Arterial Disease Clinical Trial
— OMEGA-PAD IIOfficial title:
The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation II
Verified date | July 2019 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Investigators hypothesize that high-dose n-3 polyunsaturated fatty acids (PUFA) oral supplementation will improve systemic inflammation, vascular function, and symptomatic status of patients with PAD. Investigators will explore novel mechanistic pathways by which n-3 PUFA affect PAD, evaluating the role of specialized lipid mediators involved in the resolution of inflammation.
Status | Completed |
Enrollment | 26 |
Est. completion date | September 2017 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 100 Years |
Eligibility |
Inclusion Criteria: 1. Intermittent claudication (Rutherford 1-3) 2. One of the following: 1. Resting or exercise ankle-brachial index (ABI) <0.9 2. toe pressure < 70 mm Hg 3. documentation on imaging of greater than or equal to 50% stenosis in segments of aortoiliac arteries, femoral arteries, or tibial arteries 3. Age 50 and more Exclusion Criteria: 1. Critical limb ischemia 2. Hypersensitivity/allergies to fish or seafood 3. Already on n-3 PUFA or equivalent 4. Significant renal, hepatic, and inflammatory disease 5. Concurrent severe infections 6. Acute illness (myocardial infarction, stroke, major surgery within 30 days) 7. Receiving immunosuppressive medications or steroids 8. Age < 50 |
Country | Name | City | State |
---|---|---|---|
United States | San Francisco Veterans Affairs Medical Center | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Grenon SM, Aguado-Zuniga J, Hatton JP, Owens CD, Conte MS, Hughes-Fulford M. Effects of fatty acids on endothelial cells: inflammation and monocyte adhesion. J Surg Res. 2012 Sep;177(1):e35-43. doi: 10.1016/j.jss.2012.04.010. Epub 2012 Apr 27. — View Citation
Grenon SM, Conte MS, Nosova E, Alley H, Chong K, Harris WS, Vittinghoff E, Owens CD. Association between n-3 polyunsaturated fatty acid content of red blood cells and inflammatory biomarkers in patients with peripheral artery disease. J Vasc Surg. 2013 Nov;58(5):1283-90. doi: 10.1016/j.jvs.2013.05.024. Epub 2013 Jul 2. — View Citation
Grenon SM, Hughes-Fulford M, Rapp J, Conte MS. Polyunsaturated fatty acids and peripheral artery disease. Vasc Med. 2012 Feb;17(1):51-63. doi: 10.1177/1358863X11429175. Review. — View Citation
Grenon SM, Owens CD, Alley H, Chong K, Yen PK, Harris W, Hughes-Fulford M, Conte MS. n-3 Polyunsaturated fatty acids supplementation in peripheral artery disease: the OMEGA-PAD trial. Vasc Med. 2013 Oct;18(5):263-74. doi: 10.1177/1358863X13503695. Epub 2013 Sep 19. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Walking Performance | Will improve walking distance during 6-minute walk test and improve parameters on the walking impairment questionnaire (WIQ). | 3 months | |
Primary | Systemic Inflammatory bio-markers | reduce circulating pro-inflammatory markers (PIMs) and increase pro-resolution mediators (PRMs) assayed using targeted metabolo-lipidomics, increase PRM production within peripheral circulating monocytes. | 3 months | |
Secondary | Endothelial Function | Will increase brachial artery flow-mediated vasodilation (FMD)and peripheral resistance (AiX) and decrease arterial stiffness in the lower extremities (PWV). | 3 months |
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