Platelet PAR-1 Activation in Health and Diabetes

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04280549

Collaborator

(none)

100

Enrollment

Location

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Healthy

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Platelet PAR-1 Activation in Health and Diabetes

Actual Study Start Date :

Jun 1, 2018

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Platelet Activation [One day]
Number of dilysyl-MDA cross-links formed in human platelets
Protease Activated Receptor-1 Activation [One day]
Number of cleaved PAR-1 receptors in proportion to number of uncleared PAR-1 receptors

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

Vanderbilt University Medical Center

Investigators

Principal Investigator: Joshua Beckman, MD, Vanderbilt University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Joshua Beckman, Professor, Vanderbilt University Medical Center

ClinicalTrials.gov Identifier:

NCT04280549

Other Study ID Numbers:

192207

First Posted:

Feb 21, 2020

Last Update Posted:

Jan 28, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Study Results

No Results Posted as of Jan 28, 2022