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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL114405 | U.S. NIH Grant/Contract | View source | |
| ODS | Other Identifier | Office of Dietary Supplementation (NIH), co-funder |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This study investigates the potential protective effects of fatty acid supplementation through inhibition of platelet activation. fatty acids (omega-3 and omega-6) will be evaluated for protection from agonist-mediated platelet activation in platelets from type 2 diabetics and healthy controls. Post-menopausal women with type 2 diabetes mellitus and healthy post-menopausal women will be treated with omega-3 and omega-6 fatty acid supplements to determine protection from platelet activation and thrombosis in this high risk population.
Essential fatty acids such as omega-3 and omega-6 have been shown to play important roles in regulating platelet activation, but the underlying mechanisms have not been fully elucidated as well as their true protection from thrombosis.
12-lipoxygenase oxidized fatty acids are known to play both a pro- and anti-thrombotic effect on platelets depending on the fatty acid. oxidation of arachidonic acid by 12-lipoxygenase resuts in a pro-thrombotic bioactive lipid whereas oxidation of the omega-6 fatty acid DGLA found in plant oil results in formation of a potent anti-thrombotic bioactive lipid. Determining the extent of protection from this and other bioactive lipids produced through oxygenase activity will allow for a better understanding of which fatty acid supplementation may best protect from thrombosis.
Essential fatty acids such as omega-3 (DHA/EPA) and omega-6 (DGLA) appear to be protective. However the underlying mechanism for this potential protection is not well understood. Identifying the mechanism by which these supplements protect from platelet activation may identify new approaches to preventing thrombotic events in this high risk population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy subjects for Omega-6 protection | Experimental | Platelets from healthy donors will be assessed for regulation by Primrose Oil (omega-6 fatty acid). |
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| T2DM patients for Omega-6 protection | Experimental | platelets from Type 2 diabetes mellitus (T2DM) patients will be assessed for regulation by Primrose Oil (omega-6 fatty acid). |
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| Healthy control for Omega-3 protection | Active Comparator | Platelets from healthy donors will be assessed for regulation by Fish Oil (omega-3 fatty acid). |
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| T2DM for Omega-3 protection | Active Comparator | platelets from Type 2 diabetes mellitus (T2DM) patients will be assessed for regulation by Fish Oil (omega-3 fatty acid). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primrose oil | Dietary Supplement | T2DM patients and matched controls subjects will be given Primrose oil for 2 months, followed by 2-week washout. Blood will be drawn at the beginning, during, and following treatments and platelet function will be assessed. |
| Measure | Description | Time Frame |
|---|---|---|
| platelet reactivity | decreased platelet activity ex vivo translating to protection from clot formation in vivo | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| fatty acid incorporation | measure altered levels of essential fatty acids in blood and platelets following treatment | through study completion, an average of 1 year |
| Oxylipin production | determine the oxylipin products formed following each intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael A Holinstat, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35791734 | Result | Yamaguchi A, Stanger L, Freedman JC, Prieur A, Thav R, Tena J, Holman TR, Holinstat M. Supplementation with omega-3 or omega-6 fatty acids attenuates platelet reactivity in postmenopausal women. Clin Transl Sci. 2022 Oct;15(10):2378-2391. doi: 10.1111/cts.13366. Epub 2022 Jul 25. |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| C028498 | evening primrose oil |
| D005395 | Fish Oils |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
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| Fish Oil | Dietary Supplement | T2DM patients and matched controls subjects will be given Fish oil for 2 months, followed by 2-week washout. Blood will be drawn at the beginning, during, and following treatments and platelet function will be assessed. |
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| through study completion, an average of 1 year |
| D044882 |
| Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |