Objective: The aim of this study is to determine the effects of coenzyme Q10 supplementation on metabolic inflammation profile and oxidative stress in diabetic hemodialysis patients .study design: parallel double-blind (both patients and researchers)randomized controlled clinical trial. Inclusion criteria:1- hemodialysis patients with glomerular filtration rate less than 10 or 25 ml/min with malnutrition and hypercalemy.
2- aged 45-75.
3-average blood pressure (systolic pressure 140-160 mmHg , diastolic pressure 90-100 mmHg)
4-diabetic patients according to American diabetes assossiation criteria.
Exclusion criteria: 1-unwilling to cooperate
2- hyperthyroidism and hypothyroidism
3-specific disease leading to bed.
4-malignant hypertension (systolic pressure more than 160 mmHg and diastolic pressure more than 100mmHg)
Population and sample size: 70 diabetic hemodialysis patients of eligible and referred to Akhavan Clinic affiliated to Kashan University of Medical Science, Kashan, Iran in the study will be selected. Intervention: patients will be assigned to receive either coenzyme Q10 (n=35) or placebo (n=35).
Coenzyme Q10 and placebos capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after intervention. At the beginning and end of the intervention: 12 weeks.
Outcome: Insulin metabolism markers (primary outcome) and lipid inflammation profiles and oxidative stress (secondary outcome) at study baseline and end-of-trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016081811763N30
Registration date:2017-01-24, 1395/11/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-01-24, 1395/11/05
Registrant information
Name
Gholamreza Askari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2110
Email address
askari@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Esfahan University of Medical Science
Expected recruitment start date
2017-02-05, 1395/11/17
Expected recruitment end date
2017-03-07, 1395/12/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Q10 supplementation on metabolic profile, inflammatory marker and oxidative stress in diabetic hemodialysis patients
Public title
effect of supplementation in treatment of diabetic hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
1- hemodialysis patients with glomerular filtration rate less than 10 or 25 ml/min with malnutrition and hypercalemy.
2- aged 45-75.
3-average blood pressure (systolic pressure 140-160 mmHg , diastolic pressure 90-100 mmHg)
4-diabetic patients according to American diabetes assossiation criteria.
Exclusion criteria: 1-unwilling to cooperate
2- hyperthyroidism and hypothyroidism
3-specific disease leading to bed.
4-malignant hypertension (systolic pressure more than 160 mmHg and diastolic pressure more than 100mmHg)
Age
From 45 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Isfahan University of Medical Sciences
Street address
hezarjarib street, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2016-12-25, 1395/10/05
Ethics committee reference number
IR.MUI.REC.1395.1.109
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
Insulin
Timepoint
At the beginning of the study and after 3 month intervention
Method of measurement
ELISA kit - μIU/ml
2
Description
Fasting blood sample
Timepoint
At the beginning of the study and after 3 month intervention
Method of measurement
ensymatic - mg/dl
3
Description
HOMA-IR
Timepoint
At the beginning of the study and after 3 month intervention
Method of measurement
calculation
4
Description
QUICKI
Timepoint
At the beginning of the study and after 3 month intervention
Method of measurement
calculation
5
Description
HOMA-B
Timepoint
At the beginning of the study and after 3 month intervention
Method of measurement
calculation
6
Description
HbA1C
Timepoint
At the beginning of the study and after 3 month intervention
Method of measurement
calculation - percentage
Secondary outcomes
1
Description
Nitric oxide
Timepoint
At the beginning of the study and after 3 month of intervention
Method of measurement
Spectrophotometry
2
Description
hs-CRP
Timepoint
At the beginning of the study and after 3 month of intervention
Method of measurement
ELISA kit
3
Description
TAC
Timepoint
At the beginning of the study and after 3 month of intervention
Method of measurement
Spectrophotometry
4
Description
GSH
Timepoint
At the beginning of the study and after 3 month of intervention
Method of measurement
Spectrophotometry
5
Description
HDL
Timepoint
At the beginning of the study and after 3 month of intervention
Method of measurement
Ensymatic
6
Description
Cholestrol
Timepoint
At the beginning of the study and after 3 month of intervention
Method of measurement
Ensymatic
7
Description
TG
Timepoint
At the beginning of the study and after 3 month of intervention
Method of measurement
Ensymatic
8
Description
MDA
Timepoint
At the beginning of the study and after 3 month of intervention
Method of measurement
Spectrophotometry
Intervention groups
1
Description
60 mg coenzyme Q10, twice a day, for 3 month orally
Category
Treatment - Drugs
2
Description
Placebo, twice a day, for 3 month orally
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhavan clinic
Full name of responsible person
Alireza soleimani
Street address
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
Isfahan, Hezarjarib Street, Isfahan University of Medical Sciences
City
Isfahan
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, Isfahan 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 Science
Full name of responsible person
Zatollah Asemi
Position
PHD of Nutrition
Other areas of specialty/work
Street address
Ghotbe Ravandy Boulevard, Kashan University of Medical Science
City
Kashan
Postal code
Phone
+98 3155540021712
Fax
Email
asemi_r@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Position
PHD of Nutrition
Other areas of specialty/work
Street address
Isfahan, Hezarjarib Street, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3792 3171
Fax
Email
Askari@mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Melika Fallah
Position
msc student
Other areas of specialty/work
Street address
Isfahan, Hezarjarib Street, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)