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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, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pentoxifylline | Experimental | Patients receive Pentoxifylline 400 mg po TID for 8 weeks. |
|
| Placebo | Placebo Comparator | Patients take a placebo TID for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pentoxifylline | Drug | 400mg PO TID x 8 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in PAI-1 Level | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CRP Level | Baseline and 8 weeks | |
| Change in TNF-alpha Level | Baseline and 8 weeks | |
| Changes in the Relationship Between PAI-1, CRP, and TNF-a With Therapy. |
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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
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| Name | Affiliation | Role |
|---|---|---|
| James A S Muldowney, MD | Vanderbilt University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pentoxifylline | Patients receive Pentoxifylline 400 mg po TID for 8 weeks. Pentoxifylline: 400mg PO TID x 8 weeks |
| FG001 | Placebo | Patients take a placebo TID for 8 weeks. Placebo: PO TID x 8 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pentoxifylline | Patients receive Pentoxifylline 400 mg po TID for 8 weeks. Pentoxifylline: 400mg PO TID x 8 weeks |
| BG001 | Placebo | Patients take a placebo TID for 8 weeks. Placebo: PO TID x 8 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Study was completed and submitted for publication in 2011. We do not have the complete data set to answer questions about patients who did not complete the study. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in PAI-1 Level | Posted | Mean | Standard Error | ng/ml | Baseline and 8 weeks |
|
|
The subjects were followed from baseline to 8 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pentoxifylline | Patients receive Pentoxifylline 400 mg po TID for 8 weeks. Pentoxifylline: 400mg PO TID x 8 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea/Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Muldowney | Vanderbilt University Medical Center | 615-936-1720 | james.muldowney@vanderbilt.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D010431 | Pentoxifylline |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D013805 | Theobromine |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| Placebo | Drug | PO TID x 8 weeks |
|
|
| Baseline and 8 weeks |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Study submitted for publication in 2011. Records no longer exist to answer questions about screen failures and dropouts. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Change in CRP Level | Posted | Mean | Standard Error | mg/dl | Baseline and 8 weeks |
|
|
|
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| Secondary | Change in TNF-alpha Level | TNF-a assay did not work properly. Meaningless data resulted including negative values which are impossible. | Posted | Baseline and 8 weeks |
|
|
| Secondary | Changes in the Relationship Between PAI-1, CRP, and TNF-a With Therapy. | Unable to complete analysis due to TNF-a assay failure (see Outcome measure #3) | Posted | Baseline and 8 weeks |
|
|
| 0 |
| 22 |
| 11 |
| 22 |
| EG001 | Placebo | Patients take a placebo TID for 8 weeks. Placebo: PO TID x 8 weeks | 0 | 15 | 2 | 15 |
| Allergic Reaction | Immune system disorders | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | Systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002241 | Carbohydrates |