A clinical trial to assess the effect of low dose pioglitazone in Type 2 Diabetes mellitus
Phase 4
- Conditions
- Health Condition 1: null- Type 2 Diabetes mellitus
- Registration Number
- CTRI/2014/07/004716
- Lead Sponsor
- PGIMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 90
Inclusion Criteria
•Patients on optimal doses of sulfonylurea and /or metformin
•Age between 25 years and 80 years
•Either gender
•FBS < 250 mg/dL
•HbA1c : 7 - 10 %
•Patients willing to provide written informed consent
Exclusion Criteria
•Diabetes other than type 2 diabetes mellitus
•Evidence of renal disease (S. creatinine > 1.5mg/ml)
• Evidence of liver disease (AST/ALT >3 times normal)
•H/o CCF or IHD
• Pregnant and lactating mothers and women intending pregnancy
•History of any hemoglobinopathy that may affect determination of Glycosylated Hemoglobin
•History of intolerance or hypersensitivity to pioglitazone.
•Participation in any other clinical trial with in the last 30 days
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HbA1C levelsTimepoint: Baseline <br/ ><br>End of Third month of therapy
- Secondary Outcome Measures
Name Time Method Adiponectin levelsTimepoint: Baseline <br/ ><br>End of Third month of therapy;BMITimepoint: Baseline <br/ ><br>end of First month of therapy <br/ ><br>end of Second month of therapy <br/ ><br>end of Third month of therapy;Fasting Blood GlucoseTimepoint: Baseline <br/ ><br>end of First month of therapy <br/ ><br>end of Second month of therapy <br/ ><br>end of Third month of therapy;HOMA-IRTimepoint: Baseline <br/ ><br>end of Third month of therapy;Leptin levelsTimepoint: Baseline <br/ ><br>End of Third month of therapy;Lipid profileTimepoint: Baseline <br/ ><br>End of Third month of therapy;Postprandial Blood GlucoseTimepoint: Baseline <br/ ><br>end of First month of therapy <br/ ><br>end of Second month of therapy <br/ ><br>end of Third month of therapy;Serum Creatinine levelsTimepoint: Baseline <br/ ><br>End of Third month of therapy;SGOT and SGPT levelsTimepoint: Baseline <br/ ><br>End of Third month of therapy