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
The objective of this study is to evaluate the effect of pioglitazone on left ventricular mass and function, plasma level of inflammatory, coagulative 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.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101023733N2
Registration date:2011-02-14, 1389/11/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-02-14, 1389/11/25
Registrant information
Name
Masoumeh Sadeghi
Name of organization / entity
Isfahan Cardiovascular Research Center, Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1335 9696
Email address
roohafza@crc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan Cardiovascular Research Center, Osvah Pharmaceutical Company, Army University Of Medical Sciences
Expected recruitment start date
2011-03-06, 1389/12/15
Expected recruitment end date
2011-05-05, 1390/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The effect of Pioglitazone on Cardiovascular and Psychiatric status of non-Diabetic Metabolic Syndrome Patients
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 18 years old to 65 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan Cardiovascular Research Center/Isfahan University of Medical Sciences
Street address
Seddigheh Tahereh Research and Treatment Hospital, Khorram Ave, Isfahan, IR. Iran
City
Isfahan
Postal code
Approval date
2010-10-18, 1389/07/26
Ethics committee reference number
89112
Health conditions studied
1
Description of health condition studied
Metabolic Syndrome
ICD-10 code
E88.9
ICD-10 code description
Metabolic disorder, unspecified
Primary outcomes
1
Description
Quantitative CRP
Timepoint
baseline- week 24
Method of measurement
Elisa kit
2
Description
early (E) and late (A) ventricular filling velocity
Timepoint
baseline- week 24
Method of measurement
Pulse wave Doppler Echocardiography
3
Description
Asymmetric Dimethylarginine
Timepoint
baseline- week 24
Method of measurement
Elisa kit
4
Description
Nitric Oxide
Timepoint
baseline- week 24
Method of measurement
Elisa kit
5
Description
-
Timepoint
-
Method of measurement
-
6
Description
Left Ventricular Mass
Timepoint
baseline- week 24
Method of measurement
2D and M-Mode Echocardiography
7
Description
Left Ventricular End Diastolic Diameter
Timepoint
baseline- week 24
Method of measurement
2D and M-Mode Echocardiography
8
Description
Severity of Anxiety and Depression
Timepoint
baseline- week 24
Method of measurement
Hospital Anxiety and Depression Scale (HADS) questionnaire
9
Description
Quality of Life
Timepoint
baseline- week 24
Method of measurement
EuroQol (EQ 5-D) questionnaire
10
Description
Myocardial early diastolic velocity (Em)
Timepoint
baseline- week 24
Method of measurement
Tissue Doppler Echocardiography
11
Description
stress level
Timepoint
baseline- week 24
Method of measurement
General Health Questionnaire (GHQ-12)
Secondary outcomes
1
Description
Plasma Lipoproteins
Timepoint
baseline - week 24
Method of measurement
Elisa kit
2
Description
Vital signs and General health status
Timepoint
baseline- weeks 6, 12, 18, 24
Method of measurement
Medical history and Physical Examination
3
Description
Body Mass Index and Waist circumference
Timepoint
baseline- weeks 12 and 24
Method of measurement
Scale- Tape measure
4
Description
Liver Transaminases
Timepoint
baseline- weeks 12 and 24
Method of measurement
Elisa kit
Intervention groups
1
Description
One Pioglitazone 30 mg Tablet per day for 24 weeks
Category
Treatment - Drugs
2
Description
One Placebo Tablet per day for 24 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Cardiovascular Research Center (ICRC)
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Osvah Pharmaceutical Company
Full name of responsible person
Dr. Saremi
Street address
17 Shahrivar St., Shad Abad – 7th Km. Karaj Old Road
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Osvah Pharmaceutical Company
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Army University of Medical Sciences
Full name of responsible person
Mrs. Ebrahimi
Street address
Etemad zade St.- West Fatemi Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Army University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan Cardiovascular Research Center
Full name of responsible person
Dr. Hamidreza Roohafza
Position
Assistant professor/Psychiatrist
Other areas of specialty/work
Street address
Seddigheh Tahereh Research and Treatment Hospital, Khorram Ave, Isfahan, IR. Iran
City
Isfahan
Postal code
Phone
+98 31 1335 9898
Fax
Email
roohafza@crc.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan Cardiovascular Research Center
Full name of responsible person
Dr. Masoumeh Sadeghi
Position
Associated Professor/Cardiovascular Specialist
Other areas of specialty/work
Street address
Seddigheh Tahereh Research and Treatment Hospital, Khorram Ave, Isfahan, IR. Iran
City
Isfahan
Postal code
Phone
+98 31 1335 9090
Fax
Email
sadeghimasoumeh@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)