ActivePhase 4ACTRN12611000351910

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


Sponsor

Osvah Pharmaceutical Company

Enrollment

140 participants

Start Date

Feb 25, 2011

Study Type

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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study investigates whether pioglitazone, a diabetes medication, can improve heart health and mental well-being in people who have metabolic syndrome but do not yet have diabetes. Participants must have a BMI between 25-32 and meet standard criteria for metabolic syndrome.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

One Pioglitazone 30 mg tablet per day taken orally for 24 weeks

One Pioglitazone 30 mg tablet per day taken orally for 24 weeks


Locations(1)

Isfahan, Iran, Islamic Republic Of

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