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

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

This study is currently recruiting participants.

Verified by Vanderbilt University, August 2009

First Received: October 24, 2008 Last Updated: August 11, 2009 History of Changes

Sponsor:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00780481

Purpose

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.

Condition	Intervention
Obesity	Drug: Bradykinin

Study Type:	Interventional
Study Design:	Basic Science, Open Label, Single Group Assignment
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)

Resource links provided by NLM:

MedlinePlus related topics: Obesity

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

Peak t-PA release [ Time Frame: Single Study day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Peak FMD [ Time Frame: Single Study Day ] [ Designated as safety issue: No ]
Radial Artery Elasticity [ Time Frame: Single Study Visit ] [ Designated as safety issue: No ]
Lipid levels, PAI-1 levels, CRP levels, F2 Isoprostanes and other biomarkers of inflammation and obesity. [ Time Frame: Single Study Day ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	January 2007
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Bradykinin: Experimental 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.	Drug: Bradykinin Intrabrachial - 0, 10, 20, 40 ng/100cc/min over 5 minutes at each dose.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00780481

Contacts

Contact: James AS Muldowney, III, MD	615-936-1720	james.muldowney@vanderbilt.edu
Contact: Tami Neal, RN	615-936-1720	tami.neal@vanderbilt.edu

Locations

United States, Tennessee
Vanderbilt University Medical Center	Recruiting
Nashville, Tennessee, United States, 37232
Contact: James AS Muldowney, III, MD 615-936-1750 james.muldowney@vanderbilt.edu
Contact: Tami Neal 615-936-1931 tami.neal@vanderbilt.edu
Sub-Investigator: Douglas Vaughan, MD
Sub-Investigator: Robert N Piana, MD

Sponsors and Collaborators

Vanderbilt University

Investigators

Principal Investigator:

James AS Muldowney, MD

Vanderbilt University

More Information

No publications provided

Responsible Party:	Vanderbilt University School of Medicine ( James Muldowney, M.D., F.A.C.C., Assistant Professor of Medicine )
Study ID Numbers:	061160
Study First Received:	October 24, 2008
Last Updated:	August 11, 2009
ClinicalTrials.gov Identifier:	NCT00780481 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Vanderbilt University:

Obesity
Endothelial Function
Fibrinolytic Balance
Baseline

Additional relevant MeSH terms:

Obesity
Vasodilator Agents
Bradykinin
Overweight
Cardiovascular Agents
Pharmacologic Actions
Inflammation

Body Weight
Signs and Symptoms
Pathologic Processes
Therapeutic Uses
Nutrition Disorders
Overnutrition

ClinicalTrials.gov processed this record on November 20, 2009