The Effects of Pentoxifylline on PAI-1 in an Obese Population
- Registration Number
- NCT00770328
- Lead Sponsor
- Vanderbilt University
- 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 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.
- 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-Reactive Protein are measured at week 0, 4 and 8.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pentoxifylline Pentoxifylline Patients receive Pentoxifylline 400 mg po TID for 8 weeks. Placebo Placebo Patients take a placebo TID for 8 weeks.
- Primary Outcome Measures
Name Time Method Change in PAI-1 Level Baseline and 8 weeks
- Secondary Outcome Measures
Name Time Method Change in CRP Level Baseline and 8 weeks Change in TNF-alpha Level Baseline and 8 weeks Changes in the Relationship Between PAI-1, CRP, and TNF-a With Therapy. Baseline and 8 weeks
Trial Locations
- Locations (1)
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States