Clinical trial of the effect of magnesium supplementation compared with the placebo on carotid intima-media thickness and metabolic profiles in diabetic hemodialysis patients
Objective: The aim of this study is to determine the effects of magnesium supplementation on carotid intima-media thickness (CIMT) and metabolic profiles in diabetic hemodialysis patients. Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers. Inclusion criteria: Diabetic hemodialysis patients aged 18 to 80 years will be included in the study. Exclusion criteria: Unwillingness to cooperate. Population and sample size: Among diabetic hemodialysis patients referred to Akhavan Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Intervention: Patients will be assigned into two groups to receive magnesium supplement (n=30) or placebo (n=30). Supplements and placebos are similar in shape and size. CIMT will be determined at baseline and after 24 weeks intervention. Fasting blood samples will be taken at baseline and 24 weeks after the intervention. At the beginning and end of the intervention: 24 weeks. Outcomes: Carotid intima-media thickness (primary outcome) and metabolic profiles (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017090133941N19
Registration date:2017-11-20, 1396/08/29
Registration timing:retrospective
Last update:
Update count:2
Registration date
2017-11-20, 1396/08/29
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
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2017-10-20, 1396/07/28
Expected recruitment end date
2017-11-03, 1396/08/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of magnesium supplementation compared with the placebo on carotid intima-media thickness and metabolic profiles in diabetic hemodialysis patients
Public title
Effect of magnesium supplementation in treatment of diabetic hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diabetic hemodialysis patients; aged 18 to 80 years. Exclusion criteria: Unwillingness to cooperate.
Age
From 18 years old to 80 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
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Approval date
2017-10-19, 1396/07/27
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1396.69
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease
Primary outcomes
1
Description
Mean left CIMT
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Sonography
2
Description
Maximum left CIMT
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Sonography
3
Description
Mean right CIMT
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Sonography
4
Description
Maximum right CIMT
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Sonography
Secondary outcomes
1
Description
Insulin
Timepoint
At the beginning of the study and after 24 weeks of 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
3
Description
Triglycerides
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
Total cholesterol
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Enzymatic kit
5
Description
HDL
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Enzymatic kit
6
Description
Hs-CRP
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Elisa kit
7
Description
Nitric oxide
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Spectrophotometry
8
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Spectrophotometry
9
Description
Glutathione
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Spectrophotometry
10
Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 24 weeks of intervention