The effect of coenzyme Q10 supplementation on glycemic control, inflammatory markers, lipid profile, oxidative stress and blood pressure in type 2 diabetic patients: a placebo-controlled trial
The aim of this study is to determine the effect of coenzyme Q10 supplementation on glycemic control, inflammatory markers, lipid profile, oxidative stress and blood pressure in type 2 diabetic patients. In this single blind study, a total number of 54 patients will be selected from Shiraz health care centers. They will be divided into two groups of intervention (200 mg coenzyme Q10) and control (placebo consumers) by simple random sampling and will be intervened for eight weeks. Blood samples will be collected from the fasted (12 hours) subjects at the beginning and at the end of the study. Fasting blood sugar, hemoglobin A1c, insulin, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglyceride, highly sensitive C reactive protein and malondialdehyde levels as well as insulin resistance and blood pressure are the factors which will be assessed in the patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012121711785N1
Registration date:2013-02-01, 1391/11/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-02-01, 1391/11/13
Registrant information
Name
Mahsa Moazen
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1001
Email address
moazzen@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2012-07-22, 1391/05/01
Expected recruitment end date
2012-10-22, 1391/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of coenzyme Q10 supplementation on glycemic control, inflammatory markers, lipid profile, oxidative stress and blood pressure in type 2 diabetic patients: a placebo-controlled trial
Public title
The effect of coenzyme Q10 supplementation on the management of type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Type 2 diabetic patients, with body mass index 20-30.
Exclusion criteria: Patients with any chronic renal, hepatic and gastrointestinal disorders, using anticoagulants, lipid lowering medications and β-blockers, consumption of vitamin-mineral supplements, following specific diets and smokers. In the case of decreasing or increasing the blood glucose lowering medications the patient will be excluded from the study.
Age
From 35 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Since the samples are selected by the researcher, this is a single blind study.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand St.
City
Shiraz
Postal code
1978-71345
Approval date
2012-07-15, 1391/04/25
Ethics committee reference number
CT-91-6088
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
fasting blood sugar
Timepoint
at the beginning of intervention, at the end of intervention
Method of measurement
BT 1500 autoanalyzer, unit: mg/dl
2
Description
hemoglobin A1c
Timepoint
at the beginning of intervention, at the end of intervention
Method of measurement
HPLC method, will be reported as percentage
3
Description
insulin
Timepoint
at the beginning of intervention, at the end of intervention
Method of measurement
ELISA method, unit: μIU/ml
4
Description
insulin resistance
Timepoint
at the beginning of intervention, at the end of intervention
Method of measurement
according to the formula
5
Description
high-sensitivity C-reactive protein
Timepoint
at the beginning of intervention, at the end of intervention
Method of measurement
ELISA method, unit: ng/ml
6
Description
adiponectin
Timepoint
at the beginning of intervention, at the end of intervention
Method of measurement
ELISA method, unit: μg/ml
7
Description
triglyceride
Timepoint
at the beginning of intervention, at the end of intervention
Method of measurement
BT-1500 autoanalyzer, unit: mg/dl
8
Description
total cholesterol
Timepoint
at the beginning of intervention, at the end of intervention
Method of measurement
BT-1500 autoanalyzer, unit: mg/dl
9
Description
LDL- cholesterol
Timepoint
at the beginning of intervention, at the end of intervention
Method of measurement
BT-1500 autoanalyzer, unit: mg/dl
10
Description
HDL- cholesterol
Timepoint
at the beginning of intervention, at the end of intervention
Method of measurement
BT-1500 autoanalyzer, unit: mg/dl
11
Description
malondialdehyde
Timepoint
at the beginning of intervention, at the end of intervention
Method of measurement
spectrophotometry, unit: μmol/l
12
Description
blood pressure
Timepoint
at the beginning of intervention, at the end of intervention
Method of measurement
mercury sphygmomanometer, unit: mmHg
Secondary outcomes
1
Description
hip circumference
Timepoint
at the beginning of intervention, at the end of intervention
Method of measurement
measuring with a tape measure, unit: centimeter
2
Description
weight
Timepoint
at the beginning of intervention, at the end of intervention
Method of measurement
analog scale, unit: kg
3
Description
Body Mass Index
Timepoint
at the beginning of intervention, at the end of intervention
Method of measurement
according to the formula, unit: kg/m2
4
Description
waist circumference
Timepoint
at the beginning of intervention, at the end of intervention
Method of measurement
measuring with a tape measure, unit: centimeter
Intervention groups
1
Description
coenzyme Q10 capsule, 100 mg, twice per day, for eight weeks, edible. Health Burst brand
Category
Other
2
Description
Cellulose acetate, 100 mg, two capsules per day, for eight weeks, edible, made in Shiraz School of Pharmacy
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Health Care Center
Full name of responsible person
Mahsa Moazen
Street address
Modares Blvd.
City
Shiraz
2
Recruitment center
Name of recruitment center
Abalfazl Health Care Center
Full name of responsible person
Mahsa Moazen
Street address
next to the Abalfazl mosque, Kolbeh Saadi
City
Shiraz
3
Recruitment center
Name of recruitment center
Hosseinebneali Health Care Center
Full name of responsible person
Mahsa Moazen
Street address
Ferdosi St.
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahmodini
Street address
Central building of Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mahsa Moazen
Position
MSc student of nutrition
Other areas of specialty/work
Street address
Nutrition Department, School of Health and Nutrition, Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71 1725 1001
Fax
Email
moazzen@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Zohreh Mazloom
Position
Associate professor
Other areas of specialty/work
Street address
Nutrition department, School of Health and Nutrition, Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71 1725 1001
Fax
Email
zohreh.mazloom@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahsa Moazen
Position
MSc student of nutrition
Other areas of specialty/work
Street address
Nutrition Department, School of Health and Nutrition, Shiraz University of Medical Sciences
City
Shiraz
Postal code
71645111
Phone
+98 71 1725 1001
Fax
Email
moazzen@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)