Characterization of Brachial Arterial t-PA Release, Endothelial Function, Obesity and Inflammation

Not Applicable

Terminated

• Conditions: Obesity
• Interventions: Drug: Bradykinin

• Registration Number: NCT00780481
• Lead Sponsor: Vanderbilt University

Brief Summary

T-PA release is impaired in obese subjects. In order to have a better mechanistic understanding of t-PA release, we will compare t-PA release to Flow Mediated Vasodilation, Radial Artery Tonometry, and other markers of endothelial function and oxidative stress.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2008-10-24
• Study First Submitted QC: 2008-10-24
• Study First Posted: 2008-10-27
• Primary Completion: 2011-01
• Study Completion: 2011-05
• Results First Submitted: 2017-03-16
• Status Verified: 2017-07
• Results First Submitted QC: 2017-07-13
• Last Update Submitted: 2017-07-13
• Results First Posted: 2017-07-14
• Last Update Posted: 2017-07-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bradykinin	Bradykinin	Patients will have flow mediated vasodilation and radial artery tonometry performed. They will then receive 0, 10, 20, 40 ng/100cc/min of intrabrachial bradykinin. Strain gauge plethysmography and blood sampling at each dose will be done to evaluate t-PA release. Blood will also be drawn for other biomarkers.

Primary Outcome Measures

Name	Time	Method
Peak t-PA Release	Single Study day	tPA Release

Secondary Outcome Measures

Name	Time	Method
Peak FMD	Single Study Day
Radial Artery Elasticity	Single Study Visit
Lipid Levels, PAI-1 Levels, CRP Levels, F2 Isoprostanes and Other Biomarkers of Inflammation and Obesity.	Single Study Day

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States