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

This study has been terminated.
(Lack of enrollment due to strict inclusion/exclusion criteria. Bradykinin shortage)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00780481
First Posted: October 27, 2008
Last Update Posted: July 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
James Muldowney, Vanderbilt University
  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: Intervention Model: Single Group Assignment
Masking: None (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 James Muldowney, Vanderbilt University:

Primary Outcome Measures:
  • Peak t-PA Release [ Time Frame: Single Study day ]
    tPA Release


Secondary Outcome Measures:
  • Peak FMD [ Time Frame: Single Study Day ]
  • Radial Artery Elasticity [ Time Frame: Single Study Visit ]
  • Lipid Levels, PAI-1 Levels, CRP Levels, F2 Isoprostanes and Other Biomarkers of Inflammation and Obesity. [ Time Frame: Single Study Day ]

Enrollment: 13
Actual Study Start Date: January 2007
Study Completion Date: May 2011
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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00780481


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: James AS Muldowney, MD Vanderbilt University Medical Center
  More Information

Responsible Party: James Muldowney, Assistant Professor of Medicine, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00780481     History of Changes
Other Study ID Numbers: 061160
First Submitted: October 24, 2008
First Posted: October 27, 2008
Results First Submitted: March 16, 2017
Results First Posted: July 14, 2017
Last Update Posted: July 14, 2017
Last Verified: July 2017

Keywords provided by James Muldowney, 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
Cysteine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action