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

Obesity Clinical Trial

— 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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00780481
• Other study ID #: 061160
• Status: Terminated
• Phase: N/A
• First received: October 24, 2008
• Last updated: July 13, 2017
• Start date: January 2007
• Est. completion date: May 2011

Study information

• Verified date: July 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: May 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Obesity

Intervention

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

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak t-PA Release	tPA Release	Single Study day
Secondary	Peak FMD		Single Study Day
Secondary	Radial Artery Elasticity		Single Study Visit
Secondary	Lipid Levels, PAI-1 Levels, CRP Levels, F2 Isoprostanes and Other Biomarkers of Inflammation and Obesity.		Single Study Day