Fatty Acid Regulation of Platelet Function in Diabetes

NCT02373332 | Completed

• 3 other identifiers: Michigan-114405AR01HL114405ODS
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Thrombosis; Type 2 Diabetes Mellitus

Keywords

platelets; 12-lipoxygenase; fatty acids; DGLA; DHA; EPA; 12-LOX

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Other: omega-3 and -6 fatty acids and their 12-LOX oxylipins

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.

Interventions

omega-3 and -6 fatty acids and their 12-LOX oxylipins OTHER

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

Healthy subjects

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults ages 21-70. Both female and male and no preference for race or ethnicity. Subjects will abstain from anti-platelet therapy for 10 days. Health status will be confirmed by oral questioning and written questionnaire and confirmed following blood draw prior to evaluation of platelets with fatty acid or oxylipins.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Platelets, plasma, and whole blood will be assessed for platelet reactivity and thrombosis and stored for later analysis of protein expression. DNA will be stored for assessment of levels of gene products throught to play a role in platelet reactivity.

MeSH Terms

Conditions

Thrombosis; Diabetes Mellitus, Type 2

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Michael Holinstat, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pharmacology

Study Record Dates

• First Submitted: February 20, 2015
• First Posted: February 27, 2015
• Study Start: August 1, 2013
• Primary Completion: May 21, 2019
• Study Completion: May 21, 2019
• Last Updated: June 3, 2021

Record last verified: 2021-05

Locations

US (2)