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

NCT00770328 | Completed Phase 4 Results

• 1 other identifier: 030497
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in PAI-1 Level

  Baseline and 8 weeks

Secondary Outcomes (3)

• 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.

  Baseline and 8 weeks

Study Arms (2)

Pentoxifylline

EXPERIMENTAL

Patients receive Pentoxifylline 400 mg po TID for 8 weeks.

Drug: Pentoxifylline

Placebo

PLACEBO COMPARATOR

Patients take a placebo TID for 8 weeks.

Drug: Placebo

Interventions

Pentoxifylline DRUG

400mg PO TID x 8 weeks

Also known as: Trental

Pentoxifylline

Placebo DRUG

PO TID x 8 weeks

Also known as: Sugar Pill

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Pentoxifylline; Sugars

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Carbohydrates

Results Point of Contact

• Title: James Muldowney
• Organization: Vanderbilt University Medical Center

james.muldowney@vanderbilt.edu

615-936-1720

Study Officials

• James A S Muldowney, MD

  Vanderbilt University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 9, 2008
• First Posted: October 10, 2008
• Study Start: May 1, 2003
• Primary Completion: May 1, 2009
• Study Completion: June 1, 2009
• Last Updated: November 30, 2017
• Results First Posted: November 30, 2017

Record last verified: 2017-10

Locations

US (1)