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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Vanderbilt University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00780481
First received: October 24, 2008
Last updated: August 11, 2009
Last verified: August 2009
  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

Vanderbilt University has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
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:


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
Experimental: 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.
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:

  1. Adults 18 years and greater
  2. Healthy

Exclusion criteria:

  1. PVC < 30
  2. Hypertensive subjects on ACE inhibitors
  3. Pregnant or nursing mothers
  4. Diabetic with HbA1C > 7.5 or stigmata of end organ damage (neuropathy, retinopathy, nephropathy, cardiomyopathy)
  5. Cholesterol > 30 mg/dL above NCEP accepted level based on cardiac risk.
  6. Triglycerides > 200
  7. Previously diagnosed obstructive coronary artery disease, myocardial infarction or left ventricular dysfunction (with or without a history of congestive heart failure)
  8. Renal insufficiency (Creatinine ≥ 1.5 mg/dl)
  9. History of cerebrovascular disease
  10. Any chronic inflammatory disease (rheumatologic, inflammatory bowel disease, etc)
  11. 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).
  12. Angiotensin converting enzyme inhibitor use
  13. Coagulopathy (INR ≥ 1.5, PTT ≥ 1.5 x control)
  14. Other chronic medical illnesses at the discretion of the investigators
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by Vanderbilt University:
Obesity
Endothelial Function
Fibrinolytic Balance
Baseline

Additional relevant MeSH terms:
Obesity
Inflammation
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Pathologic Processes
Bradykinin
Kininogens
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Cysteine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014