Platelet PAR-1 Activation in Health and Diabetes

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy; Type 2 Diabetes

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Type 2 diabetic and healthy subjects

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Joshua Beckman, MD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: February 18, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 21, 2020

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 192207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD that underlie results in a publication, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. (Link to be provided).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No