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

Condition(s) targeted: Obesity

Intervention: Pentoxifylline (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Vanderbilt University

Official(s) and/or principal investigator(s):
James A S Muldowney, MD, Principal Investigator, Affiliation: Vanderbilt University School of Medicine

Overall contact:
Tami Neal, RN, Phone: 615-936-1931, Email: tami.neal@vanderbilt.edu

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Change in PAI-1 level

Secondary outcome:

Change in CRP level

Change in TNF-alpha level

Changes in the relationship between PAI-1, CRP, and TNF-a with therapy.

Detailed 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.

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Tami Neal, RN, Phone: 615-936-1931, Email: tami.neal@vanderbilt.edu

Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States; Recruiting
Tami Neal, RN, Phone: 615-936-1931, Email: tami.neal@vanderbilt.edu
James A S Muldowney, Phone: 615 2984546, Email: james.muldowney@vanderbilt.edu
James Muldowney, MD, Principal Investigator
Doug Vaughan, MD, Sub-Investigator

Starting date: May 2003
Ending date: June 2009
Last updated: October 9, 2008