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

Completed · Phase 4 · Has a placebo group

Conditions studied: Inflammation

In brief

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.

Key facts

Study ID

NCT01161394

Run by

University at Buffalo

People needed

24

Expected to finish

2003-10-01

Last updated by the study team

2022-01-27

Who can join

Age: 20 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• • 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.

You may not qualify if…

• • 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

Where it is running

• Millard Fillmore gates Hospital — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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