The effect of Pioglitazone on Cardiovascular and Psychiatric status of non-Diabetic Metabolic Syndrome Patients
The Effect of Pioglitazone on Left Ventricular Mass and Function, Plasma Levels of Inflammatory and Endothelial Biomarkers and Psychiatric Indicators in non-Diabetic Patients with Metabolic Syndrome
Osvah Pharmaceutical Company
140 participants
Feb 25, 2011
Interventional
Conditions
Summary
The objective of this study is to evaluate the effect of pioglitazone on left ventricular mass and function, plasma level of inflammatory and endothelial biomarkers and psychiatric indicators in non-diabetic metabolic syndrome patients. This study is a randomized, double blind, placebo controlled trial. Males and females, aged 18 to 65 year-old with metabolic syndrome will be assigned into two groups of 70 persons each. Intervention group will receive pioglitazone 30 mg once daily and control group will receive matching placebo for 24 weeks. Plasma level of Quantitative C-reactive protein, Total Nitric oxide- Asymmetic Dimethylarginine, echocardiographic indices of left ventricular mass and function, stress level, severity of anxiety and depression and quality of life will be measured at the baseline and at the end of the trial. Patients will be followed up at weeks 6 and 18 by phone and at week 12 by interview and physical examination to evaluate medication tolerance and eventual side effects. Liver enzymes will be checked every 3 months, as well.
Eligibility
Plain Language Summary
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Interventions
One Pioglitazone 30 mg tablet per day taken orally for 24 weeks
Locations(1)
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ACTRN12611000351910