Prospective, randomized, open-label, clinical trial evaluating the effects of pioglitazone on progression of atherosclerotic plaques, endothelial function, and markers for anti-inflammatory properties/obesity/antioxidative properties
Phase 4
- Conditions
- diabetes
- Registration Number
- JPRN-UMIN000002963
- Lead Sponsor
- ational Defense Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
1) Allergy against pioglitazone 2) Administration of pioglitazone 3) Poor-controlled hypertension (DBP>110 mmHg) 4) Poor-controlled diabetes (HbA1c>10.0 %) 5) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months 6) Either level of aspartate aminotransaminase or alanine aminotransferase exceeds three-fold of the normal limits. 7) End stage renal disease 8) Symptomatic (NYHA III or IV) congestive heart failure 9) Malignancies or other diseases with poor prognosis 10) Pregnant 11) Subjects whose doctor in charge do not agree to join the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Area of atherosclerotic plaques in aorta detected by magnetic resonance imaging (MRI), 12/24 months after randomization Serum lipids (total/LDL/HDL-cholesterol, triglycerides), 6/12/24 months after randomization Flow-mediated vasodilation in forearm, 6 months after randomization Heparin-releasable EC-SOD levels, 6 months after randomization
- Secondary Outcome Measures
Name Time Method Markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), oxidative stress (8-OHdG/ MDA-LDL), early-staged kidney diseases (microalbuminuria), 6/12/24 months after randomization