Role of 12-lipoxygenase in Platelet Reactivity and Type 2 Diabetes Mellitus
NCT ID: NCT02629497
Last Updated: 2025-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
90 participants
INTERVENTIONAL
2015-11-30
2017-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Healthy subjects for Omega-6 protection
Platelets from healthy donors will be assessed for regulation by Primrose Oil (omega-6 fatty acid).
Primrose oil
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.
T2DM patients for Omega-6 protection
platelets from Type 2 diabetes mellitus (T2DM) patients will be assessed for regulation by Primrose Oil (omega-6 fatty acid).
Primrose oil
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.
Healthy control for Omega-3 protection
Platelets from healthy donors will be assessed for regulation by Fish Oil (omega-3 fatty acid).
Fish Oil
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.
T2DM for Omega-3 protection
platelets from Type 2 diabetes mellitus (T2DM) patients will be assessed for regulation by Fish Oil (omega-3 fatty acid).
Fish Oil
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.
Interventions
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Primrose oil
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.
Fish Oil
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Postmenopausal women with T2DM
* All races and ethnicities
* T2DM patients taking 1st line diabetic treatment (i.e. Metformin)
Exclusion Criteria
* NSAIDS and aspirin 1 week prior to enrollment
* Cardiovascular event within 6 months prior to enrollment
* Other anti-platelet treatment including PDE and P2Y12 inhibitors
21 Years
70 Years
FEMALE
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Michigan
OTHER
Responsible Party
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Michael Holinstat
Associate Professor
Principal Investigators
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Michael A Holinstat, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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References
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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.
Other Identifiers
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ODS
Identifier Type: OTHER
Identifier Source: secondary_id
HL 114405
Identifier Type: -
Identifier Source: org_study_id
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