Conditions: Obesity
Keywords: Plasma PAI-1 level at 0, 4, 8 weeks Plasma hsCRP level at 0, 4, 8 weeks Plasma TNF-a level at 0, 4, 8 weeks
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 37
Healthy volunteers: yes

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.

Arms:
arm 1: Patients receive Pentoxifylline 400 mg po TID for 8 weeks. arm 2: Patients take a placebo TID for 8 weeks.

Interventions: intervention 1: Pentoxifylline intervention 2: Placebo
Intervention descriptions: intervention 1: 400mg PO TID x 8 weeks intervention 2: PO TID x 8 weeks

Protocol document: