NCT02629497

Role of 12-lipoxygenase in Platelet Reactivity and Type 2 Diabetes Mellitus

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: Female
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Thrombosis
• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.
DIETARY_SUPPLEMENT	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.

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2015-12-14
• Last updated: 2025-05-30

Locations

1 site across 1 country: United States