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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
90 participants
OBSERVATIONAL
2013-08-31
2019-05-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Role of 12-lipoxygenase in Platelet Reactivity and Type 2 Diabetes Mellitus
NCT02629497
Omega-3 Fatty Acids Supplementation and Atherothrombotic Biomarkers in Type 2 Diabetes and Cardiovascular Disease.
NCT02178501
Omega-3 to Reduce Diabetes Risk in Subjects With High Number of Particles That Carry "Bad Cholesterol" in the Blood
NCT04496154
N-3 Polyunsaturated Fatty Acids to Prevent and Treat Diabetic Neuropathy
NCT05145452
The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation
NCT01310270
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Healthy subjects
Healthy subjects for oxylipin effect Platelets from healthy donors will be assessed for regulation of platelet reactivity by fatty acids and 12-lipoxygenase oxylipins.
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* African American and Caucasian
* T2DM patients on controlled medication (taking metformin)
Exclusion Criteria
* 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
21 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Michigan
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Michael Holinstat
Associate Professor of Pharmacology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael Holinstat, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Michigan
Ann Arbor, Michigan, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ODS
Identifier Type: OTHER
Identifier Source: secondary_id
Michigan-114405A
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.