This trial is active, not recruiting.

Condition obesity
Treatments pentoxifylline, placebo
Phase phase 4
Sponsor Vanderbilt University
Start date May 2003
End date May 2009
Trial size 50 participants
Trial identifier NCT00770328, 030497


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Patients receive Pentoxifylline 400 mg po TID for 8 weeks.
pentoxifylline Trental
400mg PO TID x 8 weeks
(Placebo Comparator)
Patients take a placebo TID for 8 weeks.
placebo Sugar Pill
PO TID x 8 weeks

Primary Outcomes

Change in PAI-1 level
time frame: 8 weeks

Secondary Outcomes

Change in CRP level
time frame: 8 weeks
Change in TNF-alpha level
time frame: 8 weeks
Changes in the relationship between PAI-1, CRP, and TNF-a with therapy.
time frame: 8 weeks

Eligibility Criteria

Male or female participants at least 21 years old.

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 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

Additional Information

Official title The Effects of Pentoxifylline on PAI-1 in an Obese Population
Principal investigator James A S Muldowney, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2009.
Information provided to ClinicalTrials.gov by Vanderbilt University.