Evaluation of curcumin effects on Carotid Intima-Media Thickness, pulse-wave velocity and levels of hs-CRP in diabetic patients undergoing hemodialysis
Determining the effect of curcumin on carotid intima-media thickness, pulse-wave velocity and levels of hs-CRP in diabetic patients undergoing hemodialysis
Design
Two arm parallel group randomized trial with control group, double-blind, including 60 patients. randomization is achieved by using computer software.
Settings and conduct
This study will be done on 60 diabetic patients undergoing hemodialysis in Kashan city.
Patients will be picked on Nephrology center of Shahid Beheshti hospital (associated with Kashan University of Medical Sciences) based on inclusion criteria. hs-CRP, CIMT and PWV will be measured before and after receiving the medication or placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
1. diabetic patients undergoing hemodialysis
2. age between 40 to 85
3. GFR Between 15-89 mL/min
4. SBP between 140-160 mmHg and DBP between 90-100 mmHg
5. Not pregnant or lactating
6. Not smoker or alcohol abuser
7. Not having underlying disease including cardiovascular disorders, cancer, autoimmune disorders and hypo or hyperthyroidism
8. not having conditions that cause proteinuria
Exclusion criteria :
1. underlying disease that causes admission to hospital .
2. high blood pressure (SBP>160, DBP>100)
3. Not willing to continue
4. using fluvoxamine or any kind of antioxidant drug
5. Night worker
Intervention groups
Curcumin group which receive curcumin (nanocurcumin) 80 g, daily, for 24 weeks .
control group which receive placebo .
Main outcome variables
Pulse wave velocity and Carotid intima-media thickness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200527047584N1
Registration date:2020-06-21, 1399/04/01
Registration timing:retrospective
Last update:2020-06-21, 1399/04/01
Update count:0
Registration date
2020-06-21, 1399/04/01
Registrant information
Name
Hamidreza Talari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0026
Email address
talari_hr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of curcumin effects on Carotid Intima-Media Thickness, pulse-wave velocity and levels of hs-CRP in diabetic patients undergoing hemodialysis
Public title
Evaluation of curcumin effects on vascular disease in diabetic patients undergoing hemodialysis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
GFR Between 15-89
SBP between 140-160 and DBP between 90-100 mmHg
Not pregnant or lactating
no history of smoking or alcohol abuse
no underlying condition including cardiovascular diseases , cancer , autoimmune disorders and thyroid function abnormalities
not having underlying disease that causes proteinuria
Exclusion criteria:
underlying diseases that caused admission to hospital
High blood pressure
using Fluvoxamine or any kind of antioxidant drugs
Night worker
Age
From 40 years old to 85 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple, Non-probability
With use of software
Blinding (investigator's opinion)
Double blinded
Blinding description
Radiologists and technicians who calculate Pulse wave velocity are blind and patients will be referred to them randomly .
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
Street address
Kashan University of Medical Sciences, Ghotb Ravandi St
City
Kashan
Province
Isfehan
Postal code
8115187159
Approval date
2020-02-17, 1398/11/28
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1398.130
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
2
Description of health condition studied
End stage renal disease
ICD-10 code
N18.6
ICD-10 code description
End stage renal disease
Primary outcomes
1
Description
Carotid-femoral pulse wave velocity
Timepoint
Before intervention and 24 weeks after intervention
Method of measurement
Color doppler ultrasound
2
Description
Carotid Intima-media thickness
Timepoint
Before intervention and 24 weeks after intervention