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临床试验/NCT02373332
NCT02373332已完成不适用

Fatty Acid Regulation of Platelet Function in Diabetes

University of Michigan2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2013年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
2
主要终点
inhibition of platelet activation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
21 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy subjects and T2DM patients
  • African American and Caucasian
  • T2DM patients on controlled medication (taking metformin)

排除标准

  • 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
  • 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

结局指标

主要结局

inhibition of platelet activation

时间窗: one-time blood draw

following blood draw, the ability of fatty acids or their oxylipins to inhibit platelet activation will be assessed.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Holinstat

Associate Professor of Pharmacology

University of Michigan

研究点 (2)

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