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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Vanderbilt University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00770328
First received: October 9, 2008
Last updated: January 27, 2009
Last verified: January 2009
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Pentoxifylline on PAI-1 in an Obese Population

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Change in PAI-1 level [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in CRP level [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change in TNF-alpha level [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Changes in the relationship between PAI-1, CRP, and TNF-a with therapy. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 9, 2008
Last Updated: January 27, 2009
Health Authority: United States: Institutional Review Board

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:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Pentoxifylline
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Cardiovascular Agents
Free Radical Scavengers
Antioxidants

ClinicalTrials.gov processed this record on May 23, 2013