Platelet PAR-1 Activation in Health and Diabetes

NCT04280549 | Completed

• 1 other identifier: 192207
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Healthy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Type 2 diabetic and healthy subjects

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Joshua Beckman, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 21, 2020
• Study Start: June 1, 2018
• Primary Completion: February 2, 2021
• Study Completion: February 2, 2021
• Last Updated: March 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• 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).

Locations

US (1)