Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000351910
Ethics application status
Approved
Date submitted
16/02/2011
Date registered
5/04/2011
Date last updated
12/12/2011
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
IRCT201101023733N2
Universal Trial Number (UTN)
U1111-1119-4933
Trial acronym
EPICAMP
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

Intervention/exposure
Study type
Interventional
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
Placebo

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
25/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment outside Australia
Country [1] 3207 0
Iran, Islamic Republic Of
State/province [1] 3207 0
Isfahan

Funding & Sponsors
Funding source category [1] 258521 0
University
Name [1] 258521 0
Isfahan Cardiovascular Research Center
Country [1] 258521 0
Iran, Islamic Republic Of
Primary sponsor type
Commercial sector/Industry
Name
Osvah Pharmaceutical Company
Address
17 Shahrivar St., Shad Abad – 7th Km. Karaj Old Road - Tehran
Post code: 1371845311
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 257658 0
University
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
Approved
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
18/09/2010
Approval date [1] 260491 0
18/10/2010
Ethics approval number [1] 260491 0
89112

Summary
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

Contacts
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
00983113359898
Fax 15477 0
00983113373435
Email 15477 0
roohafza@crc.mui.ac.ir
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
00983113359090
Fax 6405 0
00983113373435
Email 6405 0
sadeghimasoumeh@gmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
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Documents added automatically
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