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

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ClinicalTrials.gov Identifier: NCT00770328
Recruitment Status : Completed
First Posted : October 10, 2008
Results First Posted : November 30, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
James Muldowney, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment Phase
Obesity Drug: Pentoxifylline Drug: Placebo Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
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
Study Start Date : May 2003
Actual Primary Completion Date : May 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change in PAI-1 Level [ Time Frame: Baseline and 8 weeks ]

Secondary Outcome Measures :
  1. Change in CRP Level [ Time Frame: Baseline and 8 weeks ]
  2. Change in TNF-alpha Level [ Time Frame: Baseline and 8 weeks ]
  3. Changes in the Relationship Between PAI-1, CRP, and TNF-a With Therapy. [ Time Frame: Baseline and 8 weeks ]


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
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 angiotensin converting enzyme (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


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

Responsible Party: James Muldowney, Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00770328     History of Changes
Other Study ID Numbers: 030497
First Posted: October 10, 2008    Key Record Dates
Results First Posted: November 30, 2017
Last Update Posted: November 30, 2017
Last Verified: October 2017

Keywords provided by James Muldowney, Vanderbilt University Medical Center:
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