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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00770328
First Posted: October 10, 2008
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Vanderbilt University
  Purpose
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.
  Eligibility

Information from the National Library of Medicine

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00770328


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
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
ClinicalTrials.gov Identifier: NCT00770328     History of Changes
Other Study ID Numbers: 030497
First Submitted: October 9, 2008
First Posted: October 10, 2008
Last Update Posted: October 12, 2017
Last Verified: January 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:
Pentoxifylline
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