NCT00770328

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Pentoxifylline	400mg PO TID x 8 weeks
DRUG	Placebo	PO TID x 8 weeks

Timeline

• Start date: 2003-05-01
• Primary completion: 2009-05-01
• Completion: 2009-06-01
• First posted: 2008-10-10
• Last updated: 2017-11-30
• Results posted: 2017-11-30

Locations

1 site across 1 country: United States