Phase 4
Completed N=37
The Effects of Pentoxifylline on PAI-1 in an Obese Population
Source: ClinicalTrials.gov NCT00770328 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcomePrimary: Change in PAI-1 Level — 39.5; 31.6; 28.6; 37.9 ng/ml — p=0.0005
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in PAI-1 Level |
39.5; 31.6; 28.6; 37.9 | 0.0005 sig |
| SECONDARY Change in CRP Level |
5.2; 2.9; 4.6; 2.4 | 0.0114 sig |
| SECONDARY Change in TNF-alpha Level |
— | — |
| SECONDARY Changes in the Relationship Between PAI-1, CRP, and TNF-a With Therapy. |
— | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00770328). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.