The Effects of Pentoxifylline on PAI-1 in an Obese Population



Status:Completed
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:21 - Any
Updated:12/2/2017
Start Date:May 2003
End Date:June 2009

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Trial Summary
Trial Overview
Inclusion Criteria
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 pentoxifylline have been shown to lower PAI-1 levels in animal
models. This study tests the hypothesis that pentoxifylline will lower PAI-1 levels in human
subjects.

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-Reactive Protein are measured at week 0, 4 and 8.

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
We found this trial at
1
site
Vanderbilt University Medical Center
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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from
Nashville, TN
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