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

• Status: Completed
• Trial end date: 2003-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University at Buffalo
• Collaborator: Takeda Pharmaceuticals North America, Inc.
• Treatments: Pioglitazone

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