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, Endothelial and Thrombotic Biomarkers and Psychiatric indicators in Non-Diabetic Patients with Metabolic Syndrome

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

IRCT

Registry ID

IRCT201101023733N2

Enrollment

140

Registered

2011-02-14

Start date

2011-03-06

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome. Metabolic disorder, unspecified

Interventions

Intervention 1: One Pioglitazone 30 mg Tablet per day for 24 weeks. Intervention 2: One Placebo Tablet per day for 24 weeks.

Treatment - Drugs

Placebo

One Pioglitazone 30 mg Tablet per day for 24 weeks

One Placebo Tablet per day for 24 weeks

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

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 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Quantitative CRP. Timepoint: baseline- week 24. Method of measurement: Elisa kit.;Early (E) and late (A) ventricular filling velocity. Timepoint: baseline- week 24. Method of measurement: Pulse wave Doppler Echocardiography.;Asymmetric Dimethylarginine. Timepoint: baseline- week 24. Method of measurement: Elisa kit.;Nitric Oxide. Timepoint: baseline- week 24. Method of measurement: Elisa kit.;-. Timepoint: -. Method of measurement: -.;Left Ventricular Mass. Timepoint: baseline- week 24. Method of measurement: 2D and M-Mode Echocardiography.;Left Ventricular End Diastolic Diameter. Timepoint: baseline- week 24. Method of measurement: 2D and M-Mode Echocardiography.;Severity of Anxiety and Depression. Timepoint: baseline- week 24. Method of measurement: Hospital Anxiety and Depression Scale (HADS) questionnaire.;Quality of Life. Timepoint: baseline- week 24. Method of measurement: EuroQol (EQ 5-D) questionnaire.;Myocardial early diastolic velocity (Em). Timepoint: baseline- week 24. Method of measurement: Tissue Doppler Echocardiography.;Stress level. Timepoint: baseline- week 24. Method of measurement: General Health Questionnaire (GHQ-12).	—

Measure

Time frame

Quantitative CRP. Timepoint: baseline- week 24. Method of measurement: Elisa kit.;Early (E) and late (A) ventricular filling velocity. Timepoint: baseline- week 24. Method of measurement: Pulse wave Doppler Echocardiography.;Asymmetric Dimethylarginine. Timepoint: baseline- week 24. Method of measurement: Elisa kit.;Nitric Oxide. Timepoint: baseline- week 24. Method of measurement: Elisa kit.;-. Timepoint: -. Method of measurement: -.;Left Ventricular Mass. Timepoint: baseline- week 24. Method of measurement: 2D and M-Mode Echocardiography.;Left Ventricular End Diastolic Diameter. Timepoint: baseline- week 24. Method of measurement: 2D and M-Mode Echocardiography.;Severity of Anxiety and Depression. Timepoint: baseline- week 24. Method of measurement: Hospital Anxiety and Depression Scale (HADS) questionnaire.;Quality of Life. Timepoint: baseline- week 24. Method of measurement: EuroQol (EQ 5-D) questionnaire.;Myocardial early diastolic velocity (Em). Timepoint: baseline- week 24. Method of measurement: Tissue Doppler Echocardiography.;Stress level. Timepoint: baseline- week 24. Method of measurement: General Health Questionnaire (GHQ-12).

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Secondary

Measure	Time frame
Plasma Lipoproteins. Timepoint: baseline - week 24. Method of measurement: Elisa kit.;Vital signs and General health status. Timepoint: baseline- weeks 6, 12, 18, 24. Method of measurement: Medical history and Physical Examination.;Body Mass Index and Waist circumference. Timepoint: baseline- weeks 12 and 24. Method of measurement: Scale- Tape measure.;Liver Transaminases. Timepoint: baseline- weeks 12 and 24. Method of measurement: Elisa kit.	—

Measure

Time frame

Plasma Lipoproteins. Timepoint: baseline - week 24. Method of measurement: Elisa kit.;Vital signs and General health status. Timepoint: baseline- weeks 6, 12, 18, 24. Method of measurement: Medical history and Physical Examination.;Body Mass Index and Waist circumference. Timepoint: baseline- weeks 12 and 24. Method of measurement: Scale- Tape measure.;Liver Transaminases. Timepoint: baseline- weeks 12 and 24. Method of measurement: Elisa kit.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Hamidreza Roohafza

Isfahan Cardiovascular Research Center

roohafza@crc.mui.ac.ir+98 31 1335 9898

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 19, 2026