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Evaluate the therapeutic effects Sevelamer to reduce blood sugar levels, HbA1c, blood lipids and hs-CRP in patients with diabetic nephropathy

Protocol summary

Summary
Objectives: Evaluate the therapeutic effects of Sevelamer to reduce blood sugar levels, HbA1c, blood lipids and hs-CRP in patients with diabetic nephropathy Design: Of patients who have inclusion criteria, 30 patients had diabetic nephropathy at stage 2 to 4 and phosphorus in the range of 4 to 6.5 mg/dl of blood and blood sugar of 100 to 400 mg/dl and not receive treatment for hyperphosphatemia are selected. Setting and conduct: At baseline, for all diseases, tests include CBC with diff, BS, BUN, Cr, hs-CRP, HbA1c, Ca, P, TG, Chol, LDL (c), HDL (c) is requested and the results in the questionnaire containing demographic and disease information is recorded. Then, Sevelamer tablets given 800 mg, twice daily, with a meal. After a month of beginning treatment with Sevelamer, CBC with diff, BS, BUN, Cr, Ca, P, hsCRP again requested. At the end of the second month after the beginning of treatment, in addition to the tests conducted in the first month TG, Chol, LDL (c) and HDL (c) is requested. In the third month, HbA1c test in addition to the tests conducted in the first month is requested for patient. The results of this study are analyzed. Before starting the study of all patients, informed consent is obtained. Inclusion criteria: Treated patients due to diabetic nephropathy with 45 years Exclusion criteria: Use of certain medications, presence of associated malignancy

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016100423559N5
Registration date: 2016-11-06, 1395/08/16
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-11-06, 1395/08/16
Registrant information
Name
Somaieh Matin
Name of organization / entity
Ardabil University of Medicine Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3373 3011
Email address
s.matin@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardabil University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-06-20, 1396/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluate the therapeutic effects Sevelamer to reduce blood sugar levels, HbA1c, blood lipids and hs-CRP in patients with diabetic nephropathy
Public title
Evaluate the therapeutic effects of Sevelamer to reduce blood sugar levels, HbA1c, blood lipids and hs-CRP in patients with diabetic nephropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Treated patients due to diabetic nephropathy with (6.5% <HbA1C) And Age> 45 years Exclusion criteria: Use of chemotherapy medications, presence of associated malignancy
Age
From 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
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
Ardabil University of Medicine Sciences Ethics committee
Street address
Ardabil University of Medicine Sciences, Daneshgah street, Ardabil
City
Ardabil
Postal code
53141-56198
Approval date
2016-02-25, 1394/12/06
Ethics committee reference number
IR.ARUMS.REC.1394.113

Health conditions studied

1

Description of health condition studied
Diabetic nephropathy
ICD-10 code
NO8.3
ICD-10 code description
Diabetic nephropathy

Primary outcomes

1

Description
Lipid profile
Timepoint
At the beginning of study and 1, 2 and 3 months after intervention
Method of measurement
Lab.

2

Description
Cell blood count
Timepoint
At the beginning of study and 1, 2 and 3 months after intervention
Method of measurement
Lab.

Secondary outcomes

1

Description
HbA1c serum level
Timepoint
At the beginning of study and 1, 2 and 3 months after intervention
Method of measurement
Lab.

Intervention groups

1

Description
Treatment intentervention with sevelamer (Genian farmed Co) 800 mg two times in day for 3 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr. Hossein Fekri
Street address
Internal Medicine Department, Imam Khomeini Hospital, Shahid Jeddi street, Ardabil
City
Ardabil

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ardabil University of Medical Sciences
Full name of responsible person
Dr Shahram Habibzadeh
Street address
Ardabil University of Medical Science, Daneshgah street, Ardabil, Iran
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Hossein Fekri
Position
Internal Medicine Asisstant
Other areas of specialty/work
Street address
Department of Internal Medicine, Imam Khomeini Hospital, Ardabil University of Medical Science, Ardabil, Iran
City
Ardabil
Postal code
53141-56198
Phone
+98 45 3371 5846
Fax
Email
shamim.a1364@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Sosan Mohamadi Kobar
Position
Nephrologist, Internal Medicine Department
Other areas of specialty/work
Street address
Internal Medicine Department, Imam Khomeini Hospital, Shahid Jeddi street, Ardabil
City
Ardabil
Postal code
47531-56196
Phone
+98 45 3325 1403
Fax
Email
smk5213@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Hossein Fekri
Position
Internal Medicine Asisstant
Other areas of specialty/work
Street address
Ardabil University of Medical Sciences
City
Ardabil
Postal code
47531-56196
Phone
+98 45 3371 5846
Fax
Email
shamim.a1364@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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