The effects of selenium supplementation on advanced glycation end products, biomarkers of inflammatory and oxidative stress in diabetic nephropathy patients in comparison with placebo: a randomized double-blinded controlled clinical trial
Objective: The aim of this study is to determine the effects of selenium supplementation on advanced glycation end products (AGEs), inflammatory factor and biomarkers of oxidative stress in diabetic nephropathy patients. Study design: Randomized double-blinded controlled clinical trial. Blinding is carried out for patients and researchers and randomization in done by random table numbers. Inclusion Criteria: Patients with diabetic nephropathy aged 35 to 75 years will be included in this study. The use of substitute treatments including hormone or vitamin supplements, patients with liver, lung and chronic or acute inflammatory diseases, heart valve disease, short bowel syndrome and allergies, patients with low immune system ability (autoimmune), pregnant or lactating women will be included in this study. Exclusion Criteria: Patients who do not want to cooperate؛ diabetic patients who have others complications associated with diabetes are excluded from this study. Population and sample size: 60 patients with diabetic nephropathy who are eligible and are referred to kidney sections of Beheshti hospital and Akhavan dialysis center affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected. Intervention: Patients will be assigned to receive either selenium (intervention group: n=30) or placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 12-wk intervention. Intervention duration is 12 weeks. Outcomes: serum levels of glutathione peroxidase, an advanced glycation end products (AGE), inflammatory factors such as matrix metalloproteinase 2 (MMP2) and TGF_beta and malondialdehyde (MDA) oxidative stress factor will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015060622562N1
Registration date:2015-08-02, 1394/05/11
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2015-08-02, 1394/05/11
Registrant information
Name
Fereshteh Bahmani
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
fbahmani@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2015-07-11, 1394/04/20
Expected recruitment end date
2015-08-11, 1394/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of selenium supplementation on advanced glycation end products, biomarkers of inflammatory and oxidative stress in diabetic nephropathy patients in comparison with placebo: a randomized double-blinded controlled clinical trial
Public title
The effect of selenium on nephropathy complications of diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: type 2 diabetic patient with nephropathy as a complication؛ In women not being pregnant; without smoking and alcohol abuse; The lack of specific diseases such as cardiovascular, cancer, inflammatory diseases, autoimmune and hyper or hypo thyroid; Not having urinary tract infections and any other diseases that is causing proteinuria; No change in dose glucose-lowering drugs؛ Not taking non-steroidal and steroidal anti-inflammatory drugs, anti-oxidants drugs that interfere with the activation of matrix metalloproteinase such as tetracycline and glucocorticoids and also the lack of use of antihypertensive drugs, medications containing estrogen and progesterone؛ Non use of anticoagulation exclusion criteria: Any failure to comply with the conditions listed in each phase of the study or the patients unwillingness to continue cooperation will result in removal of the patient from study.
Age
From 35 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kashan university of medical sciences and health services
Street address
kashan university of medical sciences and health services, Ravand road
City
Kashan
Postal code
Approval date
2015-05-24, 1394/03/03
Ethics committee reference number
IR.KAUMS.REC.1394.22
Health conditions studied
1
Description of health condition studied
diabetic nephropathy
ICD-10 code
E11.2
ICD-10 code description
non-insulin-dependent diabetes mellitus with renal complications
Primary outcomes
1
Description
Matrix metalloproteinases 2 (MMP2)
Timepoint
Before and three months after intervention
Method of measurement
In serum sample will assessed by ELISA kit. ng/ml
2
Description
Protein carbonyl
Timepoint
Before and three months after intervention
Method of measurement
In serum sample will assessed by cholorimetric method
3
Description
Tumor growth factor-beta (TGF-b)
Timepoint
Before and three months after intervention
Method of measurement
In serum sample will assessed.by an enzyme-linking immunosorbent assay (ELISA) kit. pg/ml
4
Description
Gluthatione peroxidase (GPx)
Timepoint
Before and three months after intervention
Method of measurement
In serum sample will assessed.by an enzyme-linking immunosorbent assay (ELISA) kit. U/gHb
5
Description
Malondialdehyde (MAD)
Timepoint
Before and three months after intervention
Method of measurement
In serum sample will assessed.by spectrophotometric method.µmol/L
6
Description
advanced glycation end products (AGEs)
Timepoint
Before and three months after intervention
Method of measurement
In serum sample will assessed by fluorescence method
7
Description
Total Gluthatione
Timepoint
Before and three months after intervention
Method of measurement
In serum sample will assessed.by spectrophotometric method.µmol/L
8
Description
plasma total antioxidant
Timepoint
Before and three months after intervention
Method of measurement
In serum sample will assessed by cholorimetric method
9
Description
serum insulin
Timepoint
Before and three months after intervention
Method of measurement
In serum sample will assessed by ELISA kit. mU/ml
10
Description
Inflammatory factor hs-CRP
Timepoint
Before and three months after intervention
Method of measurement
In serum sample will assessed by ELISA kit. ng/ml
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: received one capsule of 200 μg selenium, daily for three months
Category
Treatment - Other
2
Description
control: received one capsule of placebo daily for three months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kidney Sections of Beheshti Hospital
Full name of responsible person
Dr.Alireza Soleimani
Street address
City
Kashan
2
Recruitment center
Name of recruitment center
Dialysis Department of Akhavan Hospital
Full name of responsible person
Street address
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Dr.Gholam Ali Hamidi
Street address
Vice chancellor for research, Kashan University of Medical Sciences ,Ravand road
City
Kashan
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, Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Dr. Fereshteh Bahmani
Position
PhD Clinical Biochemistry /Academic staff member of the Department of Clinical Biochemistry
Other areas of specialty/work
Street address
Medical Faculty,Kashan University of Medical Sciences,Ravand road
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
bahmani@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Fereshteh Bahmani
Position
PhD of Clinical Biochemistry
Other areas of specialty/work
Street address
Medical Faculty, Kashan University of Medical Sciences, Ravand road
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
bahmani@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of medical Sciences
Full name of responsible person
Dr. Fereshteh Bahmani
Position
PhD Clinical Biochemistry /Academic staff member of the Department of Clinical Biochemistry
Other areas of specialty/work
Street address
Medical faculty, Kashan University of medical Sciences, Ravand road, Kashan,Iran
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)