Investigation of the effect of selenium supplementation on gene expression levels associated with insulin, lipid and inflammatory metabolism in diabetic hemodialysis patients
Objective: The aim of this study is to determine the effects of selenium supplementation on gene expression related to insulin, lipid, and inflammation in diabetic hemodialysis patients
Design
Study design: Randomized double-blind placebo-controlled trial. Patients will be assigned into two groups to receive selenium supplement (n=20) or placebo (n=20).
Settings and conduct
Among Diabetic hemodialysis patients referred to Akhavan Clinic affiliated to Kashan University of Medical Sciences, 40 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: diabetic hemodialysis patients aged 45 to 75 years. Exclusion criteria: patients taking antioxidant and/or anti-inflammatory supplements within 3 months prior to intervention; patients with infectious diseases; patients with malignant diseases.
Intervention groups
Intervention group: Selenium supplements (Nature, California, USA), 200 µg, daily, for 24 weeks orally. Control group: placebo (Barij Essence, Kashan, Iran), daily, for 24 weeks orally.
Main outcome variables
Outcomes: Expressed levels of PPAR-γ gene (primary outcome) and gene expression related to inflammation and lipid (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170513033941N62
Registration date:2019-08-03, 1398/05/12
Registration timing:registered_while_recruiting
Last update:2019-08-03, 1398/05/12
Update count:0
Registration date
2019-08-03, 1398/05/12
Registrant information
Name
Mohammadreza Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
ostadmohammadi-vr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-09, 1398/04/18
Expected recruitment end date
2019-08-09, 1398/05/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of selenium supplementation on gene expression levels associated with insulin, lipid and inflammatory metabolism in diabetic hemodialysis patients
Public title
Selenium supplementation in the treatment of hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic hemodialysis patients aged 45 to 75 years.
Exclusion criteria:
Patients taking antioxidant and/or anti-inflammatory supplements within 3 months prior to intervention
Patients with infectious diseases
Patients with malignant diseases
Age
From 45 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 40 by SPSS software and participants will be randomly assigned into each intervention group by their numbers. The block randomization technique with 1:1 ratio will be used to achieve balanced group sizes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Akhavan clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of supplements. Supplements and placebos are in the same packaging at the Barij Essence pharmaceutical company. Only the code is written on the packages. Patients and researcher do not know the type of intervention and after analyzing the data, packet codes are decoded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University-Yazd Branch
Street address
Shahid Gomnam Boulevard, Yazd
City
Yazd
Province
Yazd
Postal code
8915813135
Approval date
2019-07-08, 1398/04/17
Ethics committee reference number
IR.IAU.YAZD.REC.1398.022
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
N18.6
ICD-10 code description
End stage renal disease
Primary outcomes
1
Description
Expressed levels of PPAR-γ gene
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
RT-PCR
Secondary outcomes
1
Description
Expressed levels of TNF gene
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
RT-PCR
2
Description
Expressed levels of VEGF gene
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
RT-PCR
3
Description
Expressed levels of TGF-β gene
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
RT-PCR
4
Description
Expressed levels of IL-1 gene
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
RT-PCR
5
Description
Expressed levels of IL-8 gene
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
RT-PCR
6
Description
Expressed levels of LDL-ox gene
Timepoint
At the beginning of the study and after 24 weeks of intervention