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

Phase 4

Active, not recruiting

• Conditions: Metabolic Syndrome; Mental health screening indicators; Metabolic and Endocrine - Other metabolic disorders; Mental Health - Other mental health disorders

• Registration Number: ACTRN12611000351910
• Lead Sponsor: Osvah Pharmaceutical Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
amount of Quantitative CRP, Asymmetric Dimethylarginine and Nitric Oxide reduction measured by ELISA kits[at baseline and then at week 24];Left Ventricular Mass, Left Ventricular End Diastolic Diameter, early (E) and late (A) ventricular filling velocity, Myocardial early diastolic velocity (Em) change measured by 2D and M-Mode, Pulse wave Doppler and Tissue Doppler Echocardiography[at baseline and then at week 24];change of stress level evaluated by General Health Questionnaire (GHQ-12), Severity of Anxiety and Depression evaluated by Hospital Anxiety and Depression Scale (HADS) questionnaire and Quality of Life evaluated by EuroQol (EQ 5-D) questionnaire[at baseline and then at week 24]

Secondary Outcome Measures

Name	Time	Method
Vital signs and General health status evaluated by Medical history taking and/or Physical Examination[at baseline and then at week 6, 12, 18 and 24];Liver Transaminases change measured by ELISA kit[at baseline and then at week 12 and 24];Change of Body Mass Index and Waist circumference[at baseline and then at week 12 and 24];change in Plasma Lipoproteins measured by ELISA kit[at baseline and then at week 24]