Objective: Sitagliptin effect on proteinuria in diabetic nephropathy
Inclusion criteria: type II diabetes, glomerular filtration rate greater than 30 and proteinuria more than 150 milligrams per deciliter.
Exclusion criteria: adverse drug reactions, exacerbation of renal failure and lack of glycemic control defined ranges.
Study population: patients referred to the clinics of Nephrology and Endocrinology of Amiralmomenin Hospital.
Sample size: 49
Intervention: A Case Study Sitagliptin 25 mg daily since the beginning of the second 3 months to the end of the study.
The primary outcome: change in proteinuria.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017022532769N1
Registration date:2017-06-13, 1396/03/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-13, 1396/03/23
Registrant information
Name
Mohammad Ali Ahmadloo
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3223 9226
Email address
drahmadloo@irimc.org
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of sitagliptin on proteinuria in diabetic patient with nephropathy.
Public title
Efect of sitagliptin on excretion of protein in diabetic
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Type 2 of diabet ; glomerular filtration rate more than 30 ; HbA1C 6.5-8.5 ; continue of previous diet , exersize & drug ; proteinuria more than 150mg/dl.
Exclusion criteria: Patient do not allow continue of study ; drug adverse reaction ; blood suger more than difined range ; exacerbation of renal failure.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
49
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Arak University of Medical Sciences - (Basij Sq. Pardis sight Mail Box 1884)
City
Arak
Postal code
۳۸۴۸۱-۷-۶۹۴۱
Approval date
2016-08-10, 1395/05/20
Ethics committee reference number
IR.ARAKMU.REC.1395.148
Health conditions studied
1
Description of health condition studied
Diabet type 2
ICD-10 code
E11.2
ICD-10 code description
E11.2 Non-insulin-dependent diabetes mellitus with renal complications
Primary outcomes
1
Description
Urine protein
Timepoint
3 mo.before , before & 3 mo. after trial
Method of measurement
24h urine protein /mg/dl
Secondary outcomes
1
Description
Hypoglycemia
Timepoint
3 month
Method of measurement
FBS check
Intervention groups
1
Description
Sitagliptin 25mg daily oral for 3 month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Dr.Mohammad Ali Ahmadloo
Street address
Arak - sardasht street - basij sq. - Amiralmomenin Hospital
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Mohammad Rafeie
Street address
Arak University of Medical Sciences - MOJTAMEH E PAYAMBAR AZAM
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Ahmadloo
Position
Internal Medicine Resident of Arak University of Medical Sciences