The Effects of Pentoxifylline on PAI-1 in an Obese Population
Recruitment status was Active, not recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||The Effects of Pentoxifylline on PAI-1 in an Obese Population|
- Change in PAI-1 level [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Change in CRP level [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Change in TNF-alpha level [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Changes in the relationship between PAI-1, CRP, and TNF-a with therapy. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||May 2003|
|Estimated Study Completion Date:||June 2009|
|Estimated Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
Patients receive Pentoxifylline 400 mg po TID for 8 weeks.
400mg PO TID x 8 weeks
Other Name: Trental
Placebo Comparator: Placebo
Patients take a placebo TID for 8 weeks.
PO TID x 8 weeks
Other Name: Sugar Pill
Obese individuals with elevated PAI-1 levels (greater than 10 ng/ml) are randomized to pentoxifylline 400mg, TID or placebo for 8 weeks. PAI-1, TNF-a and high sensitivity C-Reactive Protein are measured at week 0, 4 and 8.
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||James A S Muldowney, MD||Vanderbilt University School of Medicine|