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Effect of Pioglitazone on Oxidative Load, Inflammatory End-Points and Vascular Reactivity in Obese Non-Diabetic Patients: A Dose Ranging Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01161394
First Posted: July 13, 2010
Last Update Posted: December 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by:
University at Buffalo
  Purpose
Pioglitazone decreases oxidative load, inflammatory end points and improves vascular reactivity in obese patients in a dose dependent manner and that this effect is independent of its glucose lowering effects.

Condition Intervention Phase
Inflammation Drug: Pioglitazone 15mg Drug: pioglitazone 30mg Drug: placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Pioglitazone on Oxidative Load, Inflammatory End-Points and Vascular Reactivity in Obese Non-Diabetic Patients: A Dose Ranging Study

Resource links provided by NLM:


Further study details as provided by University at Buffalo:

Primary Outcome Measures:
  • Inflammation [ Time Frame: 12 weeks ]
    Percent change in NFkb at baseline and after 1, 2, 4, 6, and 12 weeks of pioglitazone therapy.


Secondary Outcome Measures:
  • inflammation [ Time Frame: 12 weeks ]
    TBARS (Thiobarbituric acid reactive substances), ortho and meta-tyrosine, 9-HODE and 13-HODE (hydroxyoctadecadieonic acid derivatives), Cellular/nuclear fractions and DNA binding activity of Nuclear Factor kb, Ikb (inhibitory kappa B), TNF-a(Tumor necrosis factor a), ICAM-1 (Intracellular adhesion molecule 1), VCAM-1(Vascular adhesion molecule 1), PAI-1 (Plasminogen Activator Inhibitor -1) and CRP (C-Reactive protein) and %change in vascular reactivity.


Estimated Enrollment: 24
Study Completion Date: October 2003
Arms Assigned Interventions
Experimental: Pioglitazone 15mg
8 patient will receive this drug
Drug: Pioglitazone 15mg
Experimental: pioglitazone 30mg
8 patients will get this drug
Drug: pioglitazone 30mg
Placebo Comparator: Placebo
8 patient will get this drug
Drug: placebo

Detailed Description:

This is a single center, open labeled study. A total of 24 obese patients will be recruited to participate in this study. The study will have three groups of 8 patients each. Subjects will be enrolled into each group by alternate recruitment. Subjects in group one will receive 15mg of pioglitazone; subjects in group two will receive 30 mg of pioglitazone; subjects in group three will receive placebo. All subjects will receive Pioglitazone or placebo for 6 weeks, followed by a 6-week observation period off Pioglitazone/placebo.

At baseline, and at week 1, week 2, week 4, week 6 and month 3 all patients will have blood drawn for TBARS, ortho and meta-tyrosine, 9-HODE and 13-HODE, NF, Ikb, TNF-a, ICAM-1, VCAM-1, PAI-1, AP-1, EGR-1, MMP-2, MMP-9, TIMP, CRP-1, E-Selectin, P-Selectin, Asymmetric dimethylarginine (ADMA), PAPP-A, SAA, MCP-1, IL-6, ROS generation, insulin levels, and CRP.

Post-ischemic dilation of the brachial artery will be used as an index of endothelium-mediated vasodilation. All subjects will have an oral glucose tolerance test (GTT) with 75gm of glucose at Day 0 and at Day 42. Vascular reactivity will be assessed at 0, 6, and at 12 weeks.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • • Obese (BMI>=30)

    • Age: 20 to 65 years of age inclusive
    • Without established clinical coronary artery disease (documented history or myocardial infarction, typical angina and an exercise ECG positive for ischemia or angiographic evidence of CAD)
    • Good health as evidence by History and Physical exam
    • Female subjects must be:

Postmenopausal for at least one year or Surgically incapable of childbearing (i.e. have had a hysterectomy or tubal ligation) or, if capable of childbearing a subject, must be practicing an acceptable method of contraception.

• Subject will be available for duration of the study and willing to comply with all study requirements.

Exclusion Criteria:

  • • Diabetes Mellitus

    • Allergy or sensitivity to Pioglitazone
    • Current use of Insulin therapy.
    • Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks
    • Hepatic disease (transaminase > 3 times normal)
    • Renal impairment (Creatinine clearance < 50 mL/min)
    • History of drug or alcohol abuse
    • COPD
    • Participation in any other concurrent clinical trial
    • Any other life-threatening, non-cardiac disease
    • Use of an investigational agent or therapeutic regimen within 30 days of study
    • Pregnancy or nursing
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01161394


Locations
United States, New York
Millard Fillmore gates Hospital
Buffalo, New York, United States, 14226
Sponsors and Collaborators
University at Buffalo
Takeda Pharmaceuticals North America, Inc.
Investigators
Principal Investigator: Paresh Dandona, MD Kaleida Health
  More Information

Responsible Party: Paresh Dandona, University at buffalo Kaleida Health
ClinicalTrials.gov Identifier: NCT01161394     History of Changes
Other Study ID Numbers: 1851
First Submitted: July 12, 2010
First Posted: July 13, 2010
Last Update Posted: December 15, 2015
Last Verified: July 2010

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs