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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2009 by Vanderbilt University.
Recruitment status was:  Active, not recruiting
Information provided by:
Vanderbilt University Identifier:
First received: October 9, 2008
Last updated: January 27, 2009
Last verified: January 2009
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.

Condition Intervention Phase
Obesity Drug: Pentoxifylline Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Pentoxifylline on PAI-1 in an Obese Population

Resource links provided by NLM:

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Change in PAI-1 level [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
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)
Arms Assigned Interventions
Experimental: Pentoxifylline
Patients receive Pentoxifylline 400 mg po TID for 8 weeks.
Drug: Pentoxifylline
400mg PO TID x 8 weeks
Other Name: Trental
Placebo Comparator: Placebo
Patients take a placebo TID for 8 weeks.
Drug: Placebo
PO TID x 8 weeks
Other Name: Sugar Pill

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.

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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Please refer to this study by its identifier: NCT00770328

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Principal Investigator: James A S Muldowney, MD Vanderbilt University School of Medicine
  More Information

Responsible Party: James Muldowney, M.D., F.A.C.C., Assistant Professor of Medicine, Vanderbilt University School of Medicine Identifier: NCT00770328     History of Changes
Other Study ID Numbers: 030497
Study First Received: October 9, 2008
Last Updated: January 27, 2009

Keywords provided by Vanderbilt University:
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

Additional relevant MeSH terms:
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Free Radical Scavengers
Antioxidants processed this record on August 17, 2017