Our aim in this study is to evaluate the effect of Pioglitazone on the weight, lipid profile and liver enzymes in patients with type 2 diabetes. The key inclusion criteria is to be between 35 and 75 years old on anti-diabetic drugs without any history of thioglitandione use and the main exclusion criteria is to have cirrhosis or advance congestive heart failure. In a randomized unicentral trial 220 type 2 diabetic patients from both genders referring to endocrinology clinic of Emam Reza hospital, Tabriz, Iran, will be assigned in two equal-sized groups control or intervention to receive 30 mg of pioglitazone daily for a 3-moths period. Patients in control group will not receive any drugs. Patients body weight, lipid profile, liver enzymes and fasting blood sugar level will be checked before and after the treatment to make comparisons between the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201209276712N2
Registration date:2012-12-31, 1391/10/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-12-31, 1391/10/11
Registrant information
Name
Nasser Aghamohammadzadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7850
Email address
aghamohammadzadeh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Pioglitazone on the weight, lipid profile and liver enzymes in patients with type 2 diabetes
Public title
Glutazone effect on weight, lipid profile and liver enzymes in diabetics
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Patients with the age between 35 and 75 years on anti-diabetic drugs; without any history of thiazolidindione use
Exclusion criteria: patients who do not use anti diabetic drugs regularly or don’t like to continue the study; patients with cirrhosis and advance congestive heart failure
Age
From 35 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
220
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
Tabriz University of Medical Sciences
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah Square
City
Tabriz
Postal code
51666-14756
Approval date
2012-07-02, 1391/04/12
Ethics committee reference number
9171
Health conditions studied
1
Description of health condition studied
Type 2 diabetes melitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
lipid profile
Timepoint
Before and after treatment
Method of measurement
laboratory testing
2
Description
liver enzyme
Timepoint
november 2012 to march 2013
Method of measurement
labratory
3
Description
weight
Timepoint
november 2012 to march 2013
Method of measurement
balance
Secondary outcomes
1
Description
FBS
Timepoint
2012 novamber to march2013
Method of measurement
labratory
Intervention groups
1
Description
randomized clinical trial with control group with oral 30 mg glutazone once a day for 3 month in intrvention group