Platelet PAR-1 Activation in Health and Diabetes

NCT ID: NCT04280549

Last Updated: 2025-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-01

Study Completion Date

2021-02-02

Brief Summary

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Platelet activation has been associated with bad events like heart attack and stroke. There are a variety of platelet activators that regulate how active a platelet is. We are interested in Protease-activated receptors (PAR)-1. We are currently studying PAR-1 activation in persons with severe peripheral artery disease. We seek, through this project, to understand PAR-1 activation in persons without peripheral artery disease. As many patients with peripheral artery disease have diabetes, we will also evaluate PAR-1 activation in persons with type 2 diabetes. In addition we will assess the impact of the glucagon-like peptide (GLP)-1 signaling pathway on platelet activation. Levels of platelet activation will be determined using platelet aggregation experiments and assessment of platelet-monocyte aggregates in peripheral blood.

Detailed Description

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Conditions

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Type 2 Diabetes Healthy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Subjects

Subjects will have a single visit where a short medical history/list of current medications and single blood draw will be performed.

No interventions assigned to this group

Type 2 Diabetic Subjects

Subjects will have a single visit where a short medical history/list of current medications and single blood draw will be performed.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Healthy men and women ≥60 years of age OR
* Type 2 diabetic men and women ≥60 years of age

Exclusion Criteria

* Active cancer
* Prior myocardial infarction, prior stroke, diagnosed peripheral artery disease
* Severe liver (cirrhosis, cancer, or end-stage liver disease), kidney disease (eGFR \<30 cc/min).
* Pregnancy or lactation
* Active vasculitis
* Anticipated lifespan \< 2 years
* Current use of a DOAC
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Joshua Beckman

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joshua Beckman, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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192207

Identifier Type: -

Identifier Source: org_study_id

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