Fatty Acid Regulation of Platelet Function in Diabetes

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Fatty Acid Regulation of Platelet Function in Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02373332
• Other study ID #: Michigan-114405A
• Secondary ID: R01HL114405ODS
• Status: Completed
• Start date: August 2013
• Est. completion date: May 21, 2019

Study information

• Verified date: May 2021
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study investigates the potential protective effects of altering fatty acid in the platelet as a method for prevention of platelet activation and thrombosis in type 2 diabetes mellitus. Fatty acids (omega-3 and omega-6) and their oxidized lipids will be evaluated for protection from agonist-mediated platelet activation in platelets from type 2 diabetics and healthy controls.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 21, 2019
• Est. primary completion date: May 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

• Healthy subjects and T2DM patients

• African American and Caucasian

• T2DM patients on controlled medication (taking metformin)

Exclusion Criteria:

• Dietary supplement within 2 weeks of enrollment

• Fish and plant oil supplements 2 months prior to enrollment

• NSAIDS and aspirin 1 week prior to enrollment

• Smoking

• Cardiovascular event within 6 months prior to enrollment

• Other anti-platelet treatment including phosphodiesterase (PDE) and P2Y12R inhibitors

• Estimated Glomerular Filtration Rate (eGFR) below 30 (severe renal insufficiency)

• eGFR above 90

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Thrombosis
• Type 2 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inhibition of platelet activation	following blood draw, the ability of fatty acids or their oxylipins to inhibit platelet activation will be assessed.	one-time blood draw