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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

October 9, 2008
January 27, 2009
May 2003
May 2009   (final data collection date for primary outcome measure)
Change in PAI-1 level [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00770328 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Effects of Pentoxifylline on PAI-1 in an Obese Population
The Effects of Pentoxifylline on PAI-1 in an Obese Population

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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Obesity
  • Drug: Pentoxifylline
    400mg PO TID x 8 weeks
    Other Name: Trental
  • Drug: Placebo
    PO TID x 8 weeks
    Other Name: Sugar Pill
  • Experimental: Pentoxifylline
    Patients receive Pentoxifylline 400 mg po TID for 8 weeks.
    Intervention: Drug: Pentoxifylline
  • Placebo Comparator: Placebo
    Patients take a placebo TID for 8 weeks.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
June 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00770328
030497
No
James Muldowney, M.D., F.A.C.C., Assistant Professor of Medicine, Vanderbilt University School of Medicine
Vanderbilt University
Not Provided
Principal Investigator: James A S Muldowney, MD Vanderbilt University School of Medicine
Vanderbilt University
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP