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NCT04280549 Clinical Trial

Platelet PAR-1 Activation in Health and Diabetes

Healthy Clinical Trial

Official title:
Platelet PAR-1 Activation in Health and Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04280549
Other study ID # 192207
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 1, 2018
Est. completion date November 30, 2024

Study information
Verified date February 2024
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 100
Est. completion date November 30, 2024
Est. primary completion date November 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (1)
Lead Sponsor Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Platelet Activation Number of dilysyl-MDA cross-links formed in human platelets One day
Primary Protease Activated Receptor-1 Activation Number of cleaved PAR-1 receptors in proportion to number of uncleared PAR-1 receptors One day
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