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

NCT ID: NCT00770328

Last Updated: 2017-11-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2009-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Pentoxifylline

Patients receive Pentoxifylline 400 mg po TID for 8 weeks.

Group Type EXPERIMENTAL

Pentoxifylline

Intervention Type DRUG

400mg PO TID x 8 weeks

Placebo

Patients take a placebo TID for 8 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

PO TID x 8 weeks

Interventions

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Pentoxifylline

400mg PO TID x 8 weeks

Intervention Type DRUG

Placebo

PO TID x 8 weeks

Intervention Type DRUG

Other Intervention Names

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Trental Sugar Pill

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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James Muldowney

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James A S Muldowney, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University School of Medicine

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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030497

Identifier Type: -

Identifier Source: org_study_id