Evaluation of the effect of curcuminoids supplementation on markers of insulin metabolism, biomarkers of inflammation and genes expression of TNF- and IL-1 in patients with diabetic hemodialysis
Evaluation of the effect of curcuminoids supplementation on markers of insulin metabolism, biomarkers of inflammation and genes expression of TNF-α and IL-1 in patients with diabetic nephropathy
Design
In this research, 60 patients with diabetic nephropathy who are eligible will be selected. Participants are randomly divided into two groups of intervention and control by computer software. The design of the study is parallel blind randomized clinical trial
Settings and conduct
Sixty patients with diabetic hemodialysis who are eligible and are referred to dialysis center of Akhavan clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected. Fasting blood samples will be taken at baseline and after 12 week intervention
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Diabetic hemodialysis patients; aged 40 to 85; ability to participate in the study until the end
Exclusion criteria:
Changing of the dosage of hypoglycemic drugs; use of other herbal medicines; unwillingness to cooperate
Intervention groups
Patients will be assigned to receive either curcuminoids (intervention group: n=30) or placebo (control group: n=30).
Main outcome variables
Markers of insulin metabolism (primary outcomes) and inflammatory factors, oxidative stress biomarkers and gene expression related to inflammation (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150606022562N6
Registration date:2019-02-11, 1397/11/22
Registration timing:retrospective
Last update:2019-02-11, 1397/11/22
Update count:1
Registration date
2019-02-11, 1397/11/22
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
Expected recruitment start date
2018-11-06, 1397/08/15
Expected recruitment end date
2018-11-16, 1397/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of curcuminoids supplementation on markers of insulin metabolism, biomarkers of inflammation and genes expression of TNF- and IL-1 in patients with diabetic hemodialysis
Public title
The effect of curcuminoids in patients with diabetic hemodialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic hemodialysis patients
Ability to participate in the study until the end
Aged 40 to 80 years
Exclusion criteria:
Changing of the dosage of hypoglycemic drugs
Use of other herbal medicines
Unwillingness to cooperate
Age
From 40 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed with simple method and random numbers generated by computer software which choose the random numbers. then we consider the specific numbers for both groups for example: the even numbers are for intervention group and the odd numbers are for the placebo group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants and researchers are not aware of which group is placebo or supplemented curcuminoids groups.
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, Ravand road
City
kashan
Province
Isfehan
Postal code
8715988141
Approval date
2018-11-05, 1397/08/14
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1397.065
Health conditions studied
1
Description of health condition studied
Chronic kidney disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Insulin
Timepoint
At the beginning of the study and 12 weeks after intervention
Method of measurement
Elisa kit
2
Description
Insulin resistance
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Calculation using HOMA formula
Secondary outcomes
1
Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
2
Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention