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

Sponsored by:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00770328

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 IV

MedlinePlus related topics: Obesity

Drug Information available for: Pentoxyl Pentoxifylline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Effects of Pentoxifylline on PAI-1 in an Obese Population

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
Pentoxifylline: Experimental Patients receive Pentoxifylline 400 mg po TID for 8 weeks.	Drug: Pentoxifylline 400mg PO TID x 8 weeks
Placebo: Placebo Comparator Patients take a placebo TID for 8 weeks.	Drug: Placebo PO TID x 8 weeks

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:	Vanderbilt University School of Medicine ( James Muldowney, M.D., F.A.C.C., Assistant Professor of Medicine )
Study ID Numbers:	030497
Study First Received:	October 9, 2008
Last Updated:	January 27, 2009
ClinicalTrials.gov Identifier:	NCT00770328 History of Changes
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

Study placed in the following topic categories:

Obesity
Radiation-Protective Agents
Vasodilator Agents
Antioxidants
Overweight
Cardiovascular Agents
Pentoxifylline

Body Weight
Signs and Symptoms
Phosphodiesterase Inhibitors
Plasminogen Activator Inhibitor 1
Nutrition Disorders
Overnutrition
Platelet Aggregation Inhibitors

Additional relevant MeSH terms:

Obesity
Vasodilator Agents
Radiation-Protective Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hematologic Agents
Overweight
Enzyme Inhibitors
Cardiovascular Agents
Protective Agents

Pentoxifylline
Pharmacologic Actions
Body Weight
Signs and Symptoms
Phosphodiesterase Inhibitors
Therapeutic Uses
Free Radical Scavengers
Nutrition Disorders
Overnutrition
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on May 06, 2009