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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of Pioglitazone on Cardiovascular and Psychiatric status of non-Diabetic Metabolic Syndrome Patients
Scientific title
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
Secondary ID [1] 259627 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Syndrome 261187 0
Mental health screening indicators 261357 0
Condition category
Condition code
Metabolic and Endocrine 259343 259343 0 0
Other metabolic disorders
Mental Health 259516 259516 0 0
Other mental health disorders

Study type
Description of intervention(s) / exposure
One Pioglitazone 30 mg tablet per day taken orally for 24 weeks
Intervention code [1] 258058 0
Treatment: Drugs
Comparator / control treatment
One Placebo tablet (identical in taste and appearance to the Pioglitazone Tablet but without the active ingredient) per day taken orally for 24 weeks
Control group

Primary outcome [1] 262148 0
amount of Quantitative CRP, Asymmetric Dimethylarginine and Nitric Oxide reduction measured by ELISA kits
Timepoint [1] 262148 0
at baseline and then at week 24
Primary outcome [2] 262149 0
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
Timepoint [2] 262149 0
at baseline and then at week 24
Primary outcome [3] 262150 0
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
Timepoint [3] 262150 0
at baseline and then at week 24
Secondary outcome [1] 273232 0
Vital signs and General health status evaluated by Medical history taking and/or Physical Examination
Timepoint [1] 273232 0
at baseline and then at week 6, 12, 18 and 24
Secondary outcome [2] 273233 0
Liver Transaminases change measured by ELISA kit
Timepoint [2] 273233 0
at baseline and then at week 12 and 24
Secondary outcome [3] 273234 0
Change of Body Mass Index and Waist circumference
Timepoint [3] 273234 0
at baseline and then at week 12 and 24
Secondary outcome [4] 273235 0
change in Plasma Lipoproteins measured by ELISA kit
Timepoint [4] 273235 0
at baseline and then at week 24

Key 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
Minimum age
18 Years
Maximum age
65 Years
Both males and females
Can healthy volunteers participate?
Key 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
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Active, not recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 3207 0
Iran, Islamic Republic Of
State/province [1] 3207 0

Funding & Sponsors
Funding source category [1] 258521 0
Name [1] 258521 0
Isfahan Cardiovascular Research Center
Address [1] 258521 0
Seddigheh Tahereh Research and Treatment Hospital, Khorram Ave, Isfahan
Post code: 8187698191
Country [1] 258521 0
Iran, Islamic Republic Of
Primary sponsor type
Commercial sector/Industry
Osvah Pharmaceutical Company
17 Shahrivar St., Shad Abad – 7th Km. Karaj Old Road - Tehran
Post code: 1371845311
Iran, Islamic Republic Of
Secondary sponsor category [1] 257658 0
Name [1] 257658 0
Army University of Medical Sciences
Address [1] 257658 0
Etemad zade St.- West Fatemi Ave. - Tehran
Post code: 1411718541
Country [1] 257658 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Ethics committee name [1] 260491 0
Ethics committee of Isfahan Cardiovascular Research Center affiliated to Isfahan University of Medical Sciences
Ethics committee address [1] 260491 0
Seddigheh Tahereh Research and Treatment Hospital, Khorram Ave, Isfahan
Post code: 8187698191
Ethics committee country [1] 260491 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 260491 0
Approval date [1] 260491 0
Ethics approval number [1] 260491 0

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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 32230 0
Address 32230 0
Country 32230 0
Phone 32230 0
Fax 32230 0
Email 32230 0
Contact person for public queries
Name 15477 0
Dr. Hamidreza Roohafza
Address 15477 0
Seddigheh Tahereh Research and Treatment Hospital, Khorram Ave, Isfahan
Post code: 8187698191
Country 15477 0
Iran, Islamic Republic Of
Phone 15477 0
Fax 15477 0
Email 15477 0
Contact person for scientific queries
Name 6405 0
Dr. Masoumeh Sadeghi
Address 6405 0
Seddigheh Tahereh Research and Treatment Hospital, Khorram Ave, Isfahan
Post code: 8187698191
Country 6405 0
Iran, Islamic Republic Of
Phone 6405 0
Fax 6405 0
Email 6405 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary