Endothelial Microparticles: A Novel Marker of Vascular Dysfunction

University of Colorado, Denver90 enrolled

Overview

The primary hypothesis of this proposal is that chronic kidney disease (CKD) and treatment with calcineurin inhibitors (CNIs) are each associated with the release of endothelial microparticles into the plasma. These injury-associated microparticles have a different molecular/protein composition than those released from endothelial cells in healthy patients, and their abundance correlates with vascular injury. To test this hypothesis the investigators propose a 3 arm case-controlled study including normal controls, individuals with stage III and IV CKD not receiving CNI therapy, and individuals with stage III and IV CKD post kidney transplantation receiving a CNI. The goal of this study is to measure the amount of microparticles in patients with kidney disease who have had a kidney transplant. Another goal of this study is to see if the measurements of microparticles are related to poor function of the vessels (endothelial dysfunction).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Chronic Kidney Disease

Interventions

Flow-mediated dilationOTHER

Flow-mediated dilation used to measure vascular function. The test is minimally invasive, with only a slight discomfort due to the inflation of the arm cuff.

single blood drawOTHER

single blood draw of approximately 45 mL.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: For Healthy controls: * BMI less than 40 kg/m\^2 * Able to give informed consent For Stage III or IV CKD patients: * BMI less than 40 kg/m\^2 * Able to give informed consent * An estimated Glomerular-Filtration Rate (GFR) of 20-60 mL/min/1.73m\^2 For Post-kidney transplant and stage III or IV CKD patients: * BMI less than 40 kg/m\^2 * Able to give informed consent * An estimated Glomerular-Filtration Rate (GFR) of 20-60 mL/min/1.73m\^2 Exclusion Criteria: For Healthy controls: -Women pregnant or breastfeeding For Stage III or IV CKD patients: * Women pregnant or breastfeeding * Adults with a life expectancy of less than one year * A history of significant liver disease or congestive heart failure * Hospitalization within the last three months * Active infection on antibiotic therapy * Uncontrolled hypertension (\>140/90) * Immunosuppressive therapy within the last year For Post-transplant stage III or IV CKD patients: * Women pregnant or breastfeeding * Adults with a life expectancy of less than one year * A history of significant liver disease or congestive heart failure * Hospitalization within the last three months * Active infection on antibiotic therapy * Uncontrolled hypertension (\>140/90)

Locations (2)

University of Colorado Anschutz Medical Campus; CTRC

Aurora, Colorado, United States

University of Colorado School of Medicine

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Change in Vascular Function

This will be measured with flow-mediated dilation and evaluate percent change from baseline over minutes.

Time frame: percent change from baseline over 2 minutes

Secondary Outcomes

Characterization of Microparticle source from blood analysis

A single blood draw to distinguish micro particle source characterization based upon protein, lipid and cholesterol composition.

Time frame: Single time point

Data from ClinicalTrials.gov

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