Characterization of Brachial Arterial t-PA Release, Endothelial Function, Obesity and Inflammation
Information source: Vanderbilt University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity
Intervention: Bradykinin (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Vanderbilt University Official(s) and/or principal investigator(s):
James AS Muldowney, MD, Principal Investigator, Affiliation: Vanderbilt University
Overall contact:
James AS Muldowney, III, MD, Phone: 615-936-1720, Email: james.muldowney@vanderbilt.edu
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.
Clinical Details
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 design: Basic Science, Open Label, Single Group Assignment
Primary outcome: Peak t-PA release
Secondary outcome: Peak FMDRadial Artery Elasticity Lipid levels, PAI-1 levels, CRP levels, F2 Isoprostanes and other biomarkers of inflammation and obesity.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
James AS Muldowney, III, MD, Phone: 615-936-1720, Email: james.muldowney@vanderbilt.edu
Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States; Recruiting
James AS Muldowney, III, MD, Phone: 615-936-1750, Email: james.muldowney@vanderbilt.edu
Tami Neal, Phone: 615-936-1931, Email: tami.neal@vanderbilt.edu
Douglas Vaughan, MD, Sub-Investigator
Robert N Piana, MD, Sub-Investigator
Additional Information
Starting date: January 2007
Ending date: May 2011
Last updated: August 11, 2009
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