Fatty Acid Regulation of Platelet Function in Diabetes
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|ClinicalTrials.gov Identifier: NCT02373332|
Recruitment Status : Active, not recruiting
First Posted : February 27, 2015
Last Update Posted : June 1, 2020
|Condition or disease||Intervention/treatment|
|Thrombosis Type 2 Diabetes Mellitus||Other: omega-3 and -6 fatty acids and their 12-LOX oxylipins|
12-lipoxygenase and 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 inhibition prevents platelet activation in part by inhibiting 12-lipoxygenase oxidation of free fatty acids in the platelet. These 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 results 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 12-lipoxygenase 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.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Fatty Acid Regulation of Platelet Function in Diabetes|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||May 2021|
Healthy subjects for oxylipin effect Platelets from healthy donors will be assessed for regulation of platelet reactivity by fatty acids and 12-lipoxygenase oxylipins.
Other: omega-3 and -6 fatty acids and their 12-LOX oxylipins
platelets from healthy subjects and T2DM patients will be isolated from their blood and treated with omega-3 and -6 fatty acids and their 12-LOX oxylipins of those fatty acids followed by assessment of protection from agonist-induced platelet activation and thrombosis
Type 2 diabetes mellitus (T2DM) patients
T2DM patients for oxylipin effect Platelets from healthy donors will be assessed for regulation of platelet reactivity by fatty acids and 12-lipoxygenase oxylipins.
- inhibition of platelet activation [ Time Frame: one-time blood draw ]following blood draw, the ability of fatty acids or their oxylipins to inhibit platelet activation will be assessed.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373332
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Michael Holinstat, PhD||University of Michigan|