The effect of Pioglitazone on Cardiovascular and Psychiatric status of non-Diabetic Metabolic Syndrome Patients

Phase 4

• Conditions: Metabolic Syndrome.; Metabolic disorder, unspecified

• Registration Number: IRCT201101023733N2
• Lead Sponsor: Osvah Pharmaceutical Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Inclusion Criteria: Male or Female 18 to 65 years of age, 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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified