This study designed to investigate the effects of pioglitazone on inflammatory processes in diabetic patients with kidney transplantation. Patients with diagnosis of diabetes, whom one month was passed after their transplantation, entered to the study. There were not any age or gender limitations. Cigarette smokers; patients with heart failure FC II and III; hepatitis B and C; GFR less than 30; pregnancy; acute rejection with progressive renal impairment and creatinine more than 1 mg/dl did not enter to the study. Patients divided randomly into two groups. First group received routine insulin therapy with daily one 15 mg pioglitazone tablet and second group received insulin therapy with placebo tablet for four months. Placebo tablets were produced identical in shape and size with pioglitazone by its manufacturer. Patients, researchers and data analyzer were unaware of drug compounds of two groups. At the beginning of the study height, weight and waist circumference measurements, heart, lung and lower extremity examinations carried out. Firstly, the patients’ blood samples were taken to check for uric acid, lipid profile and hs-CRP. All patients were visited monthly, their blood glucose and creatinine were controlled by experiments and if any problems or side effects were seen, patients were excluded from study. After four months treatment, examinations and laboratory tests were performed again and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014050117413N2
Registration date:2014-05-12, 1393/02/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-12, 1393/02/22
Registrant information
Name
Hamidreza Karimi-Sari
Name of organization / entity
Student Research Committee, Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 4354
Email address
hrkarimisari@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2013-06-10, 1392/03/20
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial of Effect of Pioglitazone Therapy on hs-CRP and Lipid Profile in Diabetic Patients with Renal Transplantation
Public title
Therapeutic Effect of Pioglitazone in Diabetic Patients with Renal Transplantation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients who had undergone kidney transplantation at Labbafinejad hospital within one month after transplantation and diagnosis of diabetes had been confirmed, without age or gender limitation. Exclusion criteria: Cigarette smoker; patients with heart failure FC II & III; hepatitis B and C; GFR less than 30; pregnancy; acute rejection with progressive renal impairment; creatinine more than 1 mg/dl
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
58
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 Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd, Daneshjoo Square, Evin, Tehran, IR.Iran.
City
Tehran
Postal code
Approval date
2013-06-02, 1392/03/12
Ethics committee reference number
135
Health conditions studied
1
Description of health condition studied
Insulin-dependent diabetes mellitus
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus
2
Description of health condition studied
Non-insulin-dependent diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
3
Description of health condition studied
Kidney transplant failure and rejection
ICD-10 code
T86.1
ICD-10 code description
Kidney transplant failure and rejection
Primary outcomes
1
Description
Fasting blood glucose
Timepoint
Before treatment and after four months treatment
Method of measurement
Laboratory tests
2
Description
Blood uric acid
Timepoint
Before treatment and after four months treatment
Method of measurement
Laboratory tests
3
Description
Blood hs CRP
Timepoint
Before treatment and after four months treatment
Method of measurement
Laboratory tests
4
Description
Blood Triglyceride
Timepoint
Before treatment and after four months treatment
Method of measurement
Laboratory tests
5
Description
Blood Cholesterol
Timepoint
Before treatment and after four months treatment
Method of measurement
Laboratory tests
6
Description
Low density lipoprotein (LDL)
Timepoint
Before treatment and after four months treatment
Method of measurement
Laboratory tests
7
Description
High density lipoprotein (HDL)
Timepoint
Before treatment and six months after treatment
Method of measurement
Laboratory tests
Secondary outcomes
1
Description
Weight
Timepoint
Before treatment and after four months treatment
Method of measurement
Kilograms
2
Description
Body mass index
Timepoint
Before treatment and after four month treatment
Method of measurement
kg/m2
3
Description
Waste circle
Timepoint
Before treatment and after four months treatment
Method of measurement
Centimeter
Intervention groups
1
Description
Daily one 15 mg Pioglitazone tablet addition to routine insulin therapy for four months
Category
Treatment - Drugs
2
Description
Daily one placebo tablet addition to routine insulin therapy