Safety and Efficacy of Low Dose Pioglitazone Compared with Standard Dose Pioglitazone in Type 2 Diabetes with Chronic Kidney Disease: a Randomized Controlled Trial
- Conditions
- Type 2 diabetesChronic kidney diseasepioglitazonetype 2 diabeteschronic kidney diseasefluid retention
- Registration Number
- TCTR20180424002
- Lead Sponsor
- Phramongkutklao Hospital and College of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 75
Age 18 years or older, diagnosed T2DM with stable glycemic treatment with HbA1c>8% at least 12 weeks and diagnosed CKD according to Kidney Disease: Improving Global Outcomes (KDIGO) 2012 definition and no history of treatment with pioglitzone within 12 weeks before starting the study.
active malignancy, severe heart, lung or liver disease, stroke, chronic infection, e.g., tuberculosis within one year of starting the study, limited life expectancy within 12 months, edematous state from any cause and specific contra-indications to pioglitazone including increased serum levels of liver enzyme (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >2.5 times the upper limit of normal), and history of bladder malignancy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method hemoglobinA1c 24 weeks blood test,Body composition 24 weeks bio-electrical impedance analysis
- Secondary Outcome Measures
Name Time Method Body composition 24 weeks bio-electrical impedance analysis