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Effect of sitagliptine on proteinuria in patients with diabetes type 2

Protocol summary

Study aim
Determination of the effect of sitagliptin on microalbuminuria in type 2 diabetes patients
Design
Clinical trial with control group, parallel group, triple blind, randomized, , individuals are randomly placed in one of the two intervention groups through statistical software.
Settings and conduct
The intervention group received 50 mg sitagliptin daily ( Dr. Abidi Company, Tehran, Iran), and the control group received a placebo (produced by the Pharmaceutical Faculty of the Isfahan University of Medical Sciences in the same size, shape and color). The Pharmaceutical Faculty allocated codes of A and B to these medications, and revealed the codes to the research team after completion of the clinical study. The patients were randomly assigned to treatment arms on a 1:1 basis to receive sitagliptin or a placebo. The research team members who were recording the data, the physicians who examined the patients and the person who was giving medications to the patients with codes A and B according to the randomization block groups were all blind to the group allocations
Participants/Inclusion and exclusion criteria
inclusion criteria:Type 2 diabetes with Hb A1C of 7.5-8.5 , age<80 years , GFR>60, BP<140/90 under treatment with ACEI or ARB antihypertensive drugs ( at least six months) Exclusion criteria: pregnancy, past history of malignancy, severe liver disease, psychosis, urinary tract infection, uncontrolled blood pressure, heart failure, diabetic foot ulcer, hospitalization and sitagliptin intolerance ,failure to refer and follow up
Intervention groups
The intervention group was treated with 50 mg of sitagliptin daily for 3 months The control group received daily placebo treatment for 3 months
Main outcome variables
Urine Albumin-to-Creatinine Ratio in a random urine sample

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201028049174N1
Registration date: 2020-11-07, 1399/08/17
Registration timing: retrospective

Last update: 2020-11-07, 1399/08/17
Update count: 0
Registration date
2020-11-07, 1399/08/17
Registrant information
Name
Roohollah Narimani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3273 5054
Email address
rnza1355@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
2018-03-20, 1396/12/29
Actual recruitment end date
2018-03-20, 1396/12/29
Trial completion date
2018-03-20, 1396/12/29
Scientific title
Effect of sitagliptine on proteinuria in patients with diabetes type 2
Public title
Effect of sitagliptine on proteinuria
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
diabet melitus type 2 age<80 years HbA1C<8.5% GFR>60 BP<140/90 under treatment with ACEI or ARB ( at least six months) sign written informed consent for participating
Exclusion criteria:
Peregnancy GFR<60 past history of malignancy severe liver disease, psychosis uncontrolled blood pressure (Blood pressure ≥ 140/90 despite treatment with three antihypertensive drugs) Heart failure Diabetic foot ulcer
Age
To 80 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 90
Actual sample size reached: 84
Randomization (investigator's opinion)
Randomized
Randomization description
The participants were randomly divided into two groups , were randomized into the intervention and placebo groups using the block randomization method.For randomization, a table of random numbers was used.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The intervention group received 50 mg sitagliptin daily ( Dr. Abidi Company, Tehran, Iran), and the control group received a placebo (produced by the Pharmaceutical Faculty of the Isfahan University of Medical Sciences in the same size, shape and color). The Pharmaceutical Faculty allocated codes of A and B to these medications, and revealed the codes to the research team after completion of the clinical study. The patients were randomly assigned to treatment arms on a 1:1 basis to receive sitagliptin or a placebo. The research team members who were recording the data, the physicians who examined the patients and the person who was giving medications to the patients with codes A and B according to the randomization block groups were all blind to the group allocations.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of isfahan University of Medical Sciences
Street address
Isfahn University of Medical Sciences, Hezar jarib st, Isfahan
City
isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2016-11-10, 1395/08/20
Ethics committee reference number
IR.MUI.REC.1395.3.663

Health conditions studied

1

Description of health condition studied
Diabetic nephropathy
ICD-10 code
E11.21
ICD-10 code description
Type 2 diabetes mellitus with diabetic nephropathy

Primary outcomes

1

Description
Urine Albumin-to-Creatinine Ratio
Timepoint
At baseline and 3 months after starting the drug
Method of measurement
Calculation of urine microalbumin (mg/l) divided by the urine creatinine (gr/l)

Secondary outcomes

1

Description
Blood pressure
Timepoint
At the beginning of the study, 4, 8,and 12 weeks after the start of the intervention
Method of measurement
Measurement,Blood pressure monitoring

2

Description
Body mass index
Timepoint
At the beginning of the study, 4, 8,and 12 weeks after the start of the intervention
Method of measurement
Measurement by weight in kilogram divided by height squared in meters

3

Description
HbA1C
Timepoint
At the beginning of the study and 12 weeks after the start of the intervention
Method of measurement
High Performance Liquid Chromatograpy(HPLC)

4

Description
Liver Enzymes (ALT، AST)
Timepoint
At the beginning of the study and 12 weeks after the start of the intervention
Method of measurement
Enzyme kit

5

Description
Profile Lipid (TG، LDL، HDL، total cholesterol)
Timepoint
At the beginning of the study and 12 weeks after the start of the intervention
Method of measurement
Enzyme kit

6

Description
URIC ACID
Timepoint
At the beginning of the study and 12 weeks after the start of the intervention
Method of measurement
Enzyme kit

7

Description
FBS
Timepoint
At the beginning of the study and 12 weeks after the start of the intervention
Method of measurement
Enzyme kit

8

Description
Glomerular filtration rate (GFR)
Timepoint
At the beginning of the study and 12 weeks after the start of the intervention
Method of measurement
MDRD formula

9

Description
Insulin resistance index(HOMAIR)
Timepoint
At the beginning of the study and 12 weeks after the start of the intervention
Method of measurement
HOMA-IR = (insulin * glucose ) / 405 for glycemia in mg/dL. In both cases the insulin is in mU/L

Intervention groups

1

Description
The intervention group received 50 mg sitagliptin daily ( Dr.Abidi Company, Tehran, Iran) for 12 weeks.Two blood and urine sample were collected from each participant at the baseline and at the end of the follow‐up period;
Category
Treatment - Drugs

2

Description
Control group: The control group received daily a placebo (produced by the Pharmaceutical Faculty of the Isfahan University of Medical Sciences in the same size, shape and color).Two blood and urine sample were collected from each participant at the baseline and at the end of the follow‐up period;
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Endocrine and Metabolism Research Center
Full name of responsible person
Ashraf Aminorroaya
Street address
Isfahan Endocrine and Metabolism Research Center, khoram Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1274
Email
siavash@med.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
زیبا فرج زادگان
Street address
Isfahan University of Medical Sciences, Hezar jarib Avne
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3792 8139
Email
farajzadegan@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
kachooi ali
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
endocrinology
Street address
First Floor, Goldis Medical Complex, Amadgah Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
0098313222439
Email
Kachuei@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
kachuei ali
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
endocrinology, internal medicine
Street address
First Floor, Goldis Medical Complex, Amadgah Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3222 4439
Email
Kachuei@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
kachuie
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
endocrinology
Street address
First Floor, Goldis Medical Complex, Amadgah Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3222 4439
Email
Kachuei@med.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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