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Characterization of Brachial Arterial t-PA Release, Endothelial Function, Obesity and Inflammation (P1A3B)

Primary Purpose

Obesity

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Bradykinin

About this trial

This is an interventional basic science trial for Obesity focused on measuring Obesity, Endothelial Function, Fibrinolytic Balance, Baseline

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

Adults 18 years and greater
Healthy

Exclusion criteria:

PVC < 30
Hypertensive subjects on ACE inhibitors
Pregnant or nursing mothers
Diabetic with HbA1C > 7.5 or stigmata of end organ damage (neuropathy, retinopathy, nephropathy, cardiomyopathy)
Cholesterol > 30 mg/dL above NCEP accepted level based on cardiac risk.
Triglycerides > 200
Previously diagnosed obstructive coronary artery disease, myocardial infarction or left ventricular dysfunction (with or without a history of congestive heart failure)
Renal insufficiency (Creatinine ≥ 1.5 mg/dl)
History of cerebrovascular disease
Any chronic inflammatory disease (rheumatologic, inflammatory bowel disease, etc)
Uncontrolled Stage 2 Hypertension (160/100 mmHg), or end organ damage due to hypertension (left ventricular hypertrophy, atrial fibrillation, hematuria, renal insufficiency, prior cerebrovascular disease).
Angiotensin converting enzyme inhibitor use
Coagulopathy (INR ≥ 1.5, PTT ≥ 1.5 x control)
Other chronic medical illnesses at the discretion of the investigators

Sites / Locations

Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bradykinin

Arm Description

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.

Outcomes

Primary Outcome Measures

Peak t-PA Release

tPA Release

Secondary Outcome Measures

Peak FMD

Radial Artery Elasticity

Lipid Levels, PAI-1 Levels, CRP Levels, F2 Isoprostanes and Other Biomarkers of Inflammation and Obesity.

Full Information

NCT ID

NCT00780481

First Posted

October 24, 2008

Last Updated

July 13, 2017

Sponsor

Vanderbilt University

1. Study Identification

Unique Protocol Identification Number

NCT00780481

Brief Title

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

Acronym

P1A3B

Official Title

Characterization of Brachial Arterial t-PA Release, Vasodilator Function, and Vascular Compliance and Correlation With Fibrinolytic Balance, Oxidative Stress, and Inflammation Measures (SCCOR Project 1 Aim 3B)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Terminated

Why Stopped

Lack of enrollment due to strict inclusion/exclusion criteria. Bradykinin shortage

Study Start Date

January 2007 (Actual)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

Obesity, Endothelial Function, Fibrinolytic Balance, Baseline

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bradykinin

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Bradykinin

Intervention Description

Intrabrachial - 0, 10, 20, 40 ng/100cc/min over 5 minutes at each dose.

Primary Outcome Measure Information:

Title

Peak t-PA Release

Description

tPA Release

Time Frame

Single Study day

Secondary Outcome Measure Information:

Title

Peak FMD

Time Frame

Single Study Day

Title

Radial Artery Elasticity

Time Frame

Single Study Visit

Title

Lipid Levels, PAI-1 Levels, CRP Levels, F2 Isoprostanes and Other Biomarkers of Inflammation and Obesity.

Time Frame

Single Study Day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Adults 18 years and greater Healthy Exclusion criteria: PVC < 30 Hypertensive subjects on ACE inhibitors Pregnant or nursing mothers Diabetic with HbA1C > 7.5 or stigmata of end organ damage (neuropathy, retinopathy, nephropathy, cardiomyopathy) Cholesterol > 30 mg/dL above NCEP accepted level based on cardiac risk. Triglycerides > 200 Previously diagnosed obstructive coronary artery disease, myocardial infarction or left ventricular dysfunction (with or without a history of congestive heart failure) Renal insufficiency (Creatinine ≥ 1.5 mg/dl) History of cerebrovascular disease Any chronic inflammatory disease (rheumatologic, inflammatory bowel disease, etc) Uncontrolled Stage 2 Hypertension (160/100 mmHg), or end organ damage due to hypertension (left ventricular hypertrophy, atrial fibrillation, hematuria, renal insufficiency, prior cerebrovascular disease). Angiotensin converting enzyme inhibitor use Coagulopathy (INR ≥ 1.5, PTT ≥ 1.5 x control) Other chronic medical illnesses at the discretion of the investigators

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James AS Muldowney, MD

Organizational Affiliation

Vanderbilt University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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