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Healthy subjects for Omega-6 protection for Blood Clot

Phase < 1
Waitlist Available
Led By Michael A Holinstat, PhD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Blood Clot
  • Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Blood Platelets
Secondary study objectives
Oxylipin production
fatty acid incorporation

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: T2DM patients for Omega-6 protectionExperimental Treatment1 Intervention
platelets from Type 2 diabetes mellitus (T2DM) patients will be assessed for regulation by Primrose Oil (omega-6 fatty acid).
Group II: Healthy subjects for Omega-6 protectionExperimental Treatment1 Intervention
Platelets from healthy donors will be assessed for regulation by Primrose Oil (omega-6 fatty acid).
Group III: Healthy control for Omega-3 protectionActive Control1 Intervention
Platelets from healthy donors will be assessed for regulation by Fish Oil (omega-3 fatty acid).
Group IV: T2DM for Omega-3 protectionActive Control1 Intervention
platelets from Type 2 diabetes mellitus (T2DM) patients will be assessed for regulation by Fish Oil (omega-3 fatty acid).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Primrose oil
2022
Completed Early Phase 1
~100

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,857 Previous Clinical Trials
6,437,597 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,938 Previous Clinical Trials
47,792,207 Total Patients Enrolled
Michael A Holinstat, PhDPrincipal InvestigatorUniversity of Michigan
~9 spots leftby Dec 2025
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