None listed
Conditions
Brief 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.
Interventions
One Pioglitazone 30 mg tablet per day taken orally for 24 weeks
Sponsors
Osvah Pharmaceutical Company
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Patients with Metabolic Syndrome (National Cholesterol Education Program/ATP III Criteria), New York Heart Association Functional Class 1 or 2, BMI 25 to 32 kg/m2
Exclusion criteria
Patients with type 2 diabetes (American Diabetes Association Criteria), Current or prior use of Pioglitazone or Rosiglitazone within the preceding 3 months, Current use of Glucocorticoids, Any history or evidence of ischemic heart disease, Patients with vulvular heart disease, Patients with uncontrolled hypertention (>140/90 mmHg), Patients with LV Systolic dysfunction diagnosed by Doppler Echocardiography (EF < 40%), Patients with Restrictive or Constrictive Cardiomyopathy and/or Pericarditis, Patients with Infectious Endocarditis, Patients with impaired Renal function (plasma creatinine > 1.5 mg/dl) or Hepatic function (ALT > 3 times of upper limit of normal), Chronic systemic inflammatory disease (eg. Rheumatoid disorders), Anemia (Hb < 13 mg/dl in Men & Hb < 12 mg/dl in Women), Pregnancy or Lactating, Alcohol or Drug abuse, Any debilitating medical condition
Outcome results
None listed