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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
37
400mg PO TID x 8 weeks
PO TID x 8 weeks
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Change in PAI-1 Level
Time frame: Baseline and 8 weeks
Change in CRP Level
Time frame: Baseline and 8 weeks
Change in TNF-alpha Level
Time frame: Baseline and 8 weeks
Changes in the Relationship Between PAI-1, CRP, and TNF-a With Therapy.
Time frame: Baseline and 8 weeks
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