Status:
COMPLETED
The Effects of Pentoxifylline on PAI-1 in an Obese Population
Lead Sponsor:
Vanderbilt University
Conditions:
Obesity
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief Summary
PAI-1 is elevated in obese individuals. TNF-alpha, an inflammatory mediator is believed to play a role in obesity mediated elevations in PAI-1 levels. TNF-alpha blockade with antibodies and the drug p...
Detailed Description
Obese individuals with elevated PAI-1 levels (greater than 10 ng/ml) are randomized to pentoxifylline 400mg, three times a day (TID) or placebo for 8 weeks. PAI-1, TNF-a and high sensitivity C-Reactiv...
Eligibility Criteria
Inclusion
- Inclusions: 1. A Body Mass Index of ≥ 30.0 2. Age 21 or older 3. Few or no medical problems 4. PAI-1 level ≥ 10 ng/dl
- Exclusions: 1. Cigarette use 2. Present use of angiotensin converting enzyme (ACE) Inhibitors 3. Recent cerebral and/or retinal hemorrhage 4. Intolerance to pentoxifylline or methylxanthines such as caffeine, theophylline, and theobromine 5. Presently on warfarin therapy 6. Pregnancy or breast-feeding 7. Recent surgery 8. Recent diagnosis/treatment for peptic ulcer
Exclusion
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00770328
Start Date
May 1 2003
End Date
June 1 2009
Last Update
November 30 2017
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232