Determination of the effect of linagliptin on microalbuminuria in type 2 diabetes patients with nephropathy
Design
A clinical trial with a parallel control group, double blind, randomized
Settings and conduct
This double blind clinical trial (researchers and participants) will be performed on 80 people (≥ 18 years old) with type 2 diabetes with microalbuminuria referring to the Isfahan Endocrine and Metabolism Research Center. Patients will enter this study in terms of entry and exit criteria and obtain consent form. Patients will be evaluated two weeks after the start of the study and then every 4 weeks to evaluate the side effects of the drug. Anthropometric, biochemical and blood pressure variables are evaluated using standard methods at the beginning of the study, 12 and 24 weeks after the start of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with 6.5% to 10% glycated hemoglobin (hemoglobin HbA1c) (48 to 86 mmol / mol); patients with Body Mass Index ≤ 40 kg / m²; the level of albumin to creatinine (UACR) ranged from 30 to 3000 mg / g creatinine (in three urine samples consecutive two weeks before the start of the study). Exclusion criteria: patients who consumed rapid acting insulin, rosiglitazone, pioglitazone, GLP-1 analogues, or anti-obesity drugs three months before the start of the study; patients who had myocardial infarction, stroke, or transient ischemic attack six months before the start of the study; patients with non-diabetic renal insufficiency or urinary tract infection; patients who have received kidney transplants.
Intervention groups
Patients will randomly be divided into one of two groups of drug (5 mg laggliptin) or placebo.
Main outcome variables
Blood pressure; urine Albumin-to-Creatinine ratio
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171030037093N11
Registration date:2019-05-08, 1398/02/18
Registration timing:prospective
Last update:2019-05-08, 1398/02/18
Update count:0
Registration date
2019-05-08, 1398/02/18
Registrant information
Name
Sadra Ansaripour
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 3487
Email address
st_ansari.s@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-20, 1398/02/30
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of the effect of linagliptin on microalbuminuria in type 2 diabetes patients with nephropathy
Public title
The effect of linagliptin on microalbuminuria in diabetes patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with 6.5% to 10% glycated hemoglobin (hemoglobin HbA1c) (48 to 86 mmol / mol)
Patients with BMI ≤ 40 kg / m²
The level of albumin to creatinine (UACR) ranged from 30 to 3000 mg / g creatinine (in three urine samples consecutive two weeks before the start of the study)
Exclusion criteria:
Patients who consumed rapid acting insulin, rosiglitazone, pioglitazone, GLP-1 analogues, or anti-obesity drugs three months before the start of the study
Patients who had myocardial infarction, stroke, or transient ischemic attack six months before the start of the study.
Patients with non-diabetic renal insufficiency or urinary tract infection
Patients who have received kidney transplants
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Cases are randomized using random allocation through the software. In this way, after the selection of 80 people that have the inclusion criteria, people are randomly assigned to one of the two intervention groups by statistical software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drugs were packaged in the same package by the pharmacist, and none of the patients and researchers knew about their contents.
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
2018-09-26, 1397/07/04
Ethics committee reference number
IR.MUI.MED.REC.1397.230
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
In three urine samples collected consecutively two weeks before the start of the study and two weeks after the start of the study and then every 4 weeks
Method of measurement
Experiments
2
Description
Blood pressure
Timepoint
At the beginning of the study, 12 and 24 weeks after the start of the intervention
Method of measurement
measurement
Secondary outcomes
1
Description
body mass index
Timepoint
At the beginning of the study, 12 and 24 weeks after the start of the intervention
Method of measurement
measurement
2
Description
Level glycosylated hemoglobin
Timepoint
At the beginning of the study, 12 and 24 weeks after the start of the intervention
Method of measurement
Experiments
3
Description
Glomerular filtration rate (GFR)
Timepoint
At the beginning of the study, 12 and 24 weeks after the start of the intervention
Method of measurement
MDRD formula
4
Description
Liver Enzymes (ALT، AST، ALP)
Timepoint
At the beginning of the study, 12 and 24 weeks after the start of the intervention
Method of measurement
Experiments
5
Description
Profile Lipid (TG، LDL، HDL، total cholesterol)
Timepoint
At the beginning of the study, 12 and 24 weeks after the start of the intervention
Method of measurement
Experiments
Intervention groups
1
Description
Intervention group: A group treated with lagglyptin 5 mg for 24 weeks.
Category
Treatment - Drugs
2
Description
Control group: A group treated with placebo for 24 weeks.
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, Amin Medical Center, Ebnesina Ave., Shohada Square, 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
Ziba Farajzadegan
Street address
Isfahan University of Medical Sciences, Hezar jarib Avne
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
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
Ashraf Aminorroaya
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
No. 9, Second Floor, Mulla Sadra Medical Complex, Amadgah Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3220 5915
Email
aminorroaya@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ashraf Aminorroaya
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
No. 9, Second Floor, Mulla Sadra Medical Complex, Amadgah Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3220 5915
Email
aminorroaya@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ashraf Aminorroaya
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
No. 9, Second Floor, Mulla Sadra Medical Complex, Amadgah Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3220 5915
Email
aminorroaya@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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information about the main outcome can be shared.
When the data will become available and for how long
Start the access period 4 months after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Use data to complete clinical trial studies
From where data/document is obtainable
Department of Physical Medicine and Rehabilitation
What processes are involved for a request to access data/document
after the investigation of researcher request and presentation of required documents will be accessible.