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CompletedNCT04280549Updated Mar 19, 2025

Platelet PAR-1 Activation in Health and Diabetes

An observational study in Type 2 Diabetes and Healthy, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-19.

Sponsored by Vanderbilt University Medical Center · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
60 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Type 2 Diabetes
  • Healthy

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03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 100 is below the median of 233 across 2,218 observational studies indexed under Diabetes Mellitus.

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Lead sponsor

Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.

Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Type 2 diabetic and healthy subjects

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. Platelet Activation

    Number of dilysyl-MDA cross-links formed in human platelets

    Time frame: One day

  2. Protease Activated Receptor-1 Activation

    Number of cleaved PAR-1 receptors in proportion to number of uncleared PAR-1 receptors

    Time frame: One day

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Study locations

1 site
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
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References and documents

Individual participant data

Plan to share: Yes — IPD that underlie results in a publication, after deidentification (text, tables, figures, and appendices).

Supporting information: Study protocol

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04280549
Lead sponsor
Vanderbilt University Medical Center
Responsible party
Joshua Beckman (Professor, Vanderbilt University Medical Center) — Principal investigator
First posted
Feb 21, 2020
Start date
Jun 1, 2018
Primary completion
Feb 2, 2021
Completion
Feb 2, 2021
Last update
Mar 19, 2025

Study contacts

Joshua Beckman, MD
principal investigator · Vanderbilt University Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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