The effect of sevelamer on hemoglobin A1c, blood glucose and inflammatory factors in diabetic nephropathy patients
Design
In this study, 24 participants will be selected, who are in the same range of GFR , Proteinuria and BMI .these patients will be selected randomly and divided in two groups.
Settings and conduct
Patients included in this study selected from diabetic nephropathic patients referred to (Imam Ali clinic) in Shahrekord. patients unified before study and randomized in two groups. patients and analysor will be unaware from grouping but researchor will be aware.
Participants/Inclusion and exclusion criteria
1. Age over 18 years
2. Informed patient satisfaction
3. Diabetic nephropathy
Intervention groups
The case group consisted of 24 patients with diabetic nephropathy, who are taken Sevelamer for two months and control group including 24 patients with diabetic nephropathy who are taken Placebo for two month.
Main outcome variables
HBA1C;ESR;CRP;ICAM;VCAM;BS
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191111045401N1
Registration date:2020-03-11, 1398/12/21
Registration timing:retrospective
Last update:2020-03-11, 1398/12/21
Update count:0
Registration date
2020-03-11, 1398/12/21
Registrant information
Name
Shadi Botshekan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3626 0514
Email address
mosadeghi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of Sevelamer carbonate effects on hemoglobin A1c, blood glucose and inflammatory factors status in patients with diabetic kidney disease.
Public title
Study of Sevelamer effect on nephropathic patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years.
Informed patient satisfaction
diabetic nephropathy
Exclusion criteria:
Recently received treatment of hyperphosphatemia
Have hypophosphatemia or hypercalcemia
Pregnancy
Known liver disease or active peptic ulcer5
Carbamazepine consumption
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Patients in Simple randomIzed method using two card samples that are mentioned A, B letters and divided in two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, according to the use of same capsules in both groups, participants and their carer, as well as assessor, are not aware of the content of capsules.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics cmmittee of Shahrekord Univercity of Medical Sciences
Street address
Parastar st. Shahrekord Town
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Approval date
2018-01-04, 1396/10/14
Ethics committee reference number
IR.SKUMS.REC.1397.181
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
BS
Timepoint
Before the beginning of study and two month after using the sevelamer and placebo
Method of measurement
Biochemical assay using BTand optical absorption teqniqus and centrifugation of serum by sampler
2
Description
inflamatory factors(ESR,CRP)
Timepoint
Before the beginning of study and two month after using the sevelamer and placebo
Method of measurement
quantitative qualitative
3
Description
HBA1C
Timepoint
Before the beginning of study and two month after using the sevelamer and placebo
Method of measurement
Using the optical absorption method, we first use a kind of solution that binds to the glycosylated hemoglobin and produced color then we should mesure colored HB
4
Description
inflamatory factor(ICAM,VCAM)
Timepoint
Before the beginning of study and two month after using the sevelamer and placebo
Method of measurement
Elisa(measurement the serum level of Antibody)
Secondary outcomes
1
Description
Degree of systemic inflamation
Timepoint
Befour study and two month after using the drugs
Method of measurement
Quantitative rate of Inflamatory Factor
Intervention groups
1
Description
Intervention group: diabetic nephropathic patients that given Sevelamer capsule 800 mg 3 times daily for two months before meal.
Category
Prevention
2
Description
Control group: Diabetic nephropathic patients received placebo three times daily before meal four two months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahrekord Imam Ali clinick
Full name of responsible person
Shadi Botshekan
Street address
Parastar st. Shahrekord Town
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
mosadeghi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr.Mohsen Mobini
Street address
shahrekord .Parastar st
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
mosadeghi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Shadi Botshekan
Position
Internal Medicien Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
shahrekord .Parastar st
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
mosadeghi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr.Leila Mahmoodnia
Position
Nephrologist
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
shahrekord .Parastar st
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
mosadeghi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Shadi Botshekan
Position
Internal Medicien Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Parastar st. Shahrekord Town
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
mosadeghi@yahoo.com
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