NCT02629497

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2015

Completed
10 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 14, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

1.6 years

First QC Date

January 14, 2015

Last Update Submit

May 28, 2025

Conditions

ThrombosisType 2 Diabetes Mellitus

Keywords

platelets12-lipoxygenasefatty acidsDGLADHAEPA12-LOX

Outcome Measures

Primary Outcomes (1)

  • platelet reactivity

    decreased platelet activity ex vivo translating to protection from clot formation in vivo

    through study completion, an average of 1 year

Secondary Outcomes (2)

  • fatty acid incorporation

    through study completion, an average of 1 year

  • Oxylipin production

    through study completion, an average of 1 year

Study Arms (4)

Healthy subjects for Omega-6 protection

EXPERIMENTAL

Platelets from healthy donors will be assessed for regulation by Primrose Oil (omega-6 fatty acid).

Dietary Supplement: Primrose oil

T2DM patients for Omega-6 protection

EXPERIMENTAL

platelets from Type 2 diabetes mellitus (T2DM) patients will be assessed for regulation by Primrose Oil (omega-6 fatty acid).

Dietary Supplement: Primrose oil

Healthy control for Omega-3 protection

ACTIVE COMPARATOR

Platelets from healthy donors will be assessed for regulation by Fish Oil (omega-3 fatty acid).

Dietary Supplement: Fish Oil

T2DM for Omega-3 protection

ACTIVE COMPARATOR

platelets from Type 2 diabetes mellitus (T2DM) patients will be assessed for regulation by Fish Oil (omega-3 fatty acid).

Dietary Supplement: Fish Oil

Interventions

Primrose oilDIETARY_SUPPLEMENT

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.

Healthy subjects for Omega-6 protectionT2DM patients for Omega-6 protection
Fish OilDIETARY_SUPPLEMENT

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.

Also known as: DHA/EPA
Healthy control for Omega-3 protectionT2DM for Omega-3 protection

Eligibility Criteria

Age21 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subjects and T2DM patients
  • Postmenopausal women with T2DM
  • All races and ethnicities
  • T2DM patients taking 1st line diabetic treatment (i.e. Metformin)

You may not qualify if:

  • 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 PDE and P2Y12 inhibitors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • Yamaguchi A, Stanger L, Freedman JC, Prieur A, Thav R, Tena J, Holman TR, Holinstat M. Supplementation with omega-3 or omega-6 fatty acids attenuates platelet reactivity in postmenopausal women. Clin Transl Sci. 2022 Oct;15(10):2378-2391. doi: 10.1111/cts.13366. Epub 2022 Jul 25.

    PMID: 35791734BACKGROUND

MeSH Terms

Conditions

ThrombosisDiabetes Mellitus, Type 2

Interventions

evening primrose oilFish Oils

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

OilsLipids

Study Officials

  • Michael A Holinstat, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 14, 2015

First Posted

December 14, 2015

Study Start

November 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

May 30, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)