The goal of this randomized clinical trial is comparison of efficacy of metformin and pioglitazone at reduction in hs_CRP level in the patients with type II DM. In this study, 40 patients with DM that have inclusion and exclusion criteria are randomly assigned to receive Metformin 500mg/bd orally for 3 months or Pioglitazone 30 mg/daily orally for 3 months. hs_CRP level will be compared at the end of this study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109067482N1
Registration date:2011-10-17, 1390/07/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-10-17, 1390/07/25
Registrant information
Name
Ramak Ghavam
Name of organization / entity
Bouali Hospital
Country
Iran (Islamic Republic of)
Phone
+98 28 1336 0084
Email address
rghavam@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research Qazvin University of Medical Sciences
Expected recruitment start date
2011-04-30, 1390/02/10
Expected recruitment end date
2011-08-01, 1390/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Differential effects of metformin and pioglithazone on hs-CRP in patients with type II DM.
Public title
Differential effects of metformin and pioglithazone on hs-CRP in patients with type II DM.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diabetic patients (type 2) receiving diet or monotherapy by sulphonylurea, HbA1C≥7.5 and FBS≥140
Exclusion criteria: known case of inflammatory disease such as IBD, RA, vascultis, recent infection in one month suffering from malignancy, receiving other drug that decrease CRP level .[COX inhibitor (ASA, Celecoxib ), platlete aggregation inhibitor (clopidogrel, abciximab ), lipid lowering agents (Statins, Ezetimibe, Fenofibrate, Niacin, B blockers, antioxidants (vit E), ACEIs, ARBs ,CCBs except Amlodipine, Tamoxifen], Soye isoflavon enriched food; consumption of oral estrogen that increase CRP level, hypersensitivity to Metformin or Pioglitazone, Insulin use, Corticosteroid use, Cr >1.4 mg/dl, severe abnormal liver function test, pregnancy
Age
From 21 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Boali Hospital, Qazvin, Iran
City
Qazvin
Postal code
3413786165
Approval date
2011-04-27, 1390/02/07
Ethics committee reference number
20/2924/د
Health conditions studied
1
Description of health condition studied
diabetes mellitus II
ICD-10 code
E11
ICD-10 code description
non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
hsCRP
Timepoint
before study and 3 months after treatment
Method of measurement
Kit for CRP_ Latex Inhanced Immunoturbidimetric Assay A Quantitative Test for C-Reactive Protein Determination by Parsazmun company (unitage: mg/L)
Secondary outcomes
1
Description
HbA1C
Timepoint
before study and 3 months after treatment
Method of measurement
Kit for HbA1C in whole blood with Immunoturbidimetric Assay, a Quantitative Test by Parsazmun Company (unitage: % )
Intervention groups
1
Description
Pioglitazone 30 mg/daily, orally for 3 months
Category
Treatment - Drugs
2
Description
Metformin 500mg/bd orally for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin University of Medical Sciences
Full name of responsible person
Dr Ramak Ghavam
Street address
Qazvin Boualisina Hos.
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Ramak Ghavam
Street address
Qazvin Boualisina Hos.
City
Qazvin
Grant name
معاونت پزوهشی دانشگاه علوم پزشکی قزوین
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
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
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Ramak Ghavam
Position
Internist MD.
Other areas of specialty/work
Street address
Iran,Qazvin, Boualisina Hos.
City
Qazvin
Postal code
3413786165
Phone
+98 28 1333 3036
Fax
+98 28 1332 6033
Email
rghavam@qums.ac.ir ramak.ghavam@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Ramak Ghavam
Position
Internist MD.
Other areas of specialty/work
Street address
Qazvin Boualisina Hos.
City
Qazvin
Postal code
3413786165
Phone
+98 28 1333 3036
Fax
+98 28 1332 6033
Email
rghavam@qums.ac.irramak.ghavam@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Ramak Ghavam
Position
Internist MD.
Other areas of specialty/work
Street address
Qazvin Boualisina Hos.
City
Qazvin
Postal code
34137-86165
Phone
+98 28 1336 0084
Fax
+98 28 1332 6033
Email
rghavam@qums.ac.irramak.ghavam@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)