Protocol summary

Summary
This double-blind study comparing interventional prospective study is to determine the effect of pioglitazone on blood glucose, inflammatory markers and oxidative stress in diabetic patients receiving insulin after renal transplantation on 60 patients with diabetes recently kidney transplants have been done. The hospital's research center in Tehran will Labbafinejad martyr. The pioglitazone group will take the medication (30mg / d until glycemic control is achieved) and the second group will receive placebo for 4 months. Incoming patients to the study, including patients with diabetes, which is one month before the transplant, renal function should be stable and should be treated with insulin. Individuals with any history of having epidural early acute febrile and 30 ml / min GFR At baseline, hepatitis B, C, (New York Heart Association II-IV) CHF, pregnancy, received pulse corticosteroids, Acute rejection (disorder progressive renal an increase in creatinine mg / dl 1 and GFR drops below ml / min 30) 2 weeks before the study were excluded. The main objective of the study to achieve a fasting blood glucose 90-130 mg / dl and BS ≤ 160 mg / dl, and insulin dose will be calculated based on the. Intervals will visit patients every two weeks. Blood samples of 15 ml of venous blood to measure blood glucose levels, HbA1c, inflammatory markers: ESR, CRP, Faktvrhayaksydatyv stress: total protein carbonyls and malondialdehyde, IL-18 will be collected. The difference in the two groups during the medication is given.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012121811807N1
Registration date: 2013-01-17, 1391/10/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-01-17, 1391/10/28
Registrant information
Name
Ali Kharazmkia
Name of organization / entity
Shahid Beheshti University of Medical Sciences, Pharmacy faculty
Country
Iran (Islamic Republic of)
Phone
+98 21 2291 2501
Email address
a.kharazmkia@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-08-22, 1392/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Pioglitazone on Blood glucose , inflammatory and oxidative stress markers after kidney transplantation in diabetic patients which are receiving Insulin
Public title
Effect of Pioglitazone on kidney transplantation in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-diabetis mellitus. 2- stable renal function at the initiation of study or 1 month after transplantation. 3- using insulin before study Exclusion criteria: 1- acute febrile episodes. 2- GFR less than 30 ml/dl before the study. 3-hepatitis B , C. 4- CHF (New York Heart Association II-IV) 5-pregnancy. 6-receiving pulse corticostroids. 7-Acute rejection at 2 week before of study starting.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Shahid beheshti pharmacy faculty
Street address
Niayesh junction - Valiasr Str.
City
tehran
Postal code
Approval date
2012-12-09, 1391/09/19
Ethics committee reference number
1391-1-94-9617

Health conditions studied

1

Description of health condition studied
Diabetis
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus

2

Description of health condition studied
Transplanted kidney
ICD-10 code
Z94.0
ICD-10 code description
transplanted kidney

Primary outcomes

1

Description
malondialdehyd plasma level
Timepoint
at the begining and end
Method of measurement
Pg/mL

2

Description
total protein carbonyls plasma level
Timepoint
at the begining and end
Method of measurement
Pg/mL kit

3

Description
IL-18 plasma level
Timepoint
at the begining and end
Method of measurement
(Pg/mL) kit

4

Description
Fast blood glucose
Timepoint
monthly
Method of measurement
kit ( mg/dL)

5

Description
ESR level
Timepoint
monthly
Method of measurement
(Pg/mL) kit

6

Description
CRP plasma level
Timepoint
monthly
Method of measurement
(ng/mL) kit

7

Description
HbA1C level
Timepoint
monthly
Method of measurement
(mIU/mL) kit

Secondary outcomes

empty

Intervention groups

1

Description
intervention group: 30 mg Pioglitazone once daily for 4 month
Category
Treatment - Drugs

2

Description
control group: placebo tablet once daily for 4 month
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Labafi nejad hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Research and Technology, Shahid beheshti pharmacy faculty
Full name of responsible person
Dr. Afshin Zarghi
Street address
Valiasr street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology, Shahid beheshti pharmacy faculty
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Kharazmkia
Position
Resident of Pharmacotherapy
Other areas of specialty/work
Street address
Pharmacy faculty
City
Tehran
Postal code
Phone
+98 912 227 5713
Fax
Email
a.kharazmkia@sbmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shadi Ziaee
Position
Asistant professor
Other areas of specialty/work
Street address
Valiasr street
City
Tehran
Postal code
Phone
+98 912 346 1497
Fax
Email
shadi_z73@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shadi Ziaee
Position
Asistant of professor
Other areas of specialty/work
Street address
Pharmacy faculty
City
tehran
Postal code
Phone
+98 912 346 1497
Fax
Email
shadi_z73@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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