Status:
COMPLETED
Effect of Pioglitazone on Oxidative Load, Inflammatory End-Points and Vascular Reactivity in Obese Non-Diabetic Patients: A Dose Ranging Study
Lead Sponsor:
University at Buffalo
Collaborating Sponsors:
Takeda Pharmaceuticals North America, Inc.
Conditions:
Inflammation
Eligibility:
All Genders
20-65 years
Phase:
PHASE4
Brief 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...
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...
Eligibility Criteria
Inclusion
- • 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
- • 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2003
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01161394
End Date
October 1 2003
Last Update
January 27 2022
Active Locations (1)
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1
Millard Fillmore gates Hospital
Buffalo, New York, United States, 14226