Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT01161394
Eligibility 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT01161394
Study Brief:
Protocol Section:
NCT01161394