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Effects of coenzyme Q10 on paraxonase, total antioxidant capacity, malondialdehyde, hs-CRP, lipid profile and glycemic control in patients with type 2 diabetes

Protocol summary

Summary
Coenzyme Q10 is a lipophilic antioxidant. Studies have shown that its serum levels decrease in patients with diabetes. The objective of this study is to assess effects of coenzyme Q10 as an adjunctive treatment to hypoglycemic agents on oxidative stress, lipid peroxidation, glycemic control and inflammatory markers in patients with type 2 diabetes mellitus. Fifty patients with type 2 diabetes will be randomly allocated to receive daily either 150 mg coenzyme Q10 or a placebo for 12 weeks. Patients will be referred from Institute of Endocrinology and Metabolism, Iran University of Medical Sciences. Ten-milliliter fasting blood samples will be taken at the beginning and at the end of study. Serum paraoxonase activity, total antioxidant capacity, malondialdehyde, hs-CRP, TG, TC, LDL, HDL, FBS, insulin and HbA1C will be determined in the blood samples. Weight, height and blood pressure will be measured at the beginning and at the end of the study. Food intake and physical activity will be assessed at baseline and after weeks 4, 8 and 12. For analysis of data paired sample t-test and independent t-test will be used. .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138806102394N1
Registration date: 2011-04-24, 1390/02/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-04-24, 1390/02/04
Registrant information
Name
Shima Jazayeri
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4805
Email address
sjazayeri@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2009-11-06, 1388/08/15
Expected recruitment end date
2010-05-05, 1389/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of coenzyme Q10 on paraxonase, total antioxidant capacity, malondialdehyde, hs-CRP, lipid profile and glycemic control in patients with type 2 diabetes
Public title
Effects of coenzyme Q10 on paraxonase, total antioxidant capacity, malondialdehyde, hs-CRP, lipid profile and glycemic control in patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- Patients with type 2 diabetes 2- Willing to participate 3- Duration of type 2 diabetes > 1 year 4- HbA1c<9% 5-TG<400 mg/dL \ Exclusion criteria: 1-BMI>40 2- Past history of MI or stroke 3-Patients with any of the following conditions: liver disease, kidney disease, or thyroid disease 4-Supplement use for at least 8 weeks before intervention till the end of study 5- Treatment with warfarin 6-BP>160/90 7-Pregnancy and lactation 8-Compliance<70% 9-Change in type or dose of medication for at least 8 weeks before intervention till the end of study 10-Treatment with insulin
Age
From 40 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 50
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 Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd, Tehran, Iran
City
Tehran
Postal code
Approval date
2027-12-31, 1406/10/10
Ethics committee reference number
2155/5د/26/پ

Health conditions studied

1

Description of health condition studied
type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
paraxonase
Timepoint
before intervention, 12 weeks after intervention
Method of measurement
spectrophotometry

2

Description
Total antioxidant capacity
Timepoint
before intervention, 12 weeks after intervention
Method of measurement
FRAP

3

Description
MDA
Timepoint
before intervention, 12 weeks after intervention
Method of measurement
spectrophotometry

4

Description
Hs-CRP
Timepoint
before intervention, 12 weeks after intervention
Method of measurement
turbidometry

5

Description
triglyceride
Timepoint
before intervention, 12 weeks after intervention
Method of measurement
Gop-PAP

6

Description
TC
Timepoint
before intervention, 12 weeks after intervention
Method of measurement
enzymatic

7

Description
LDL
Timepoint
before intervention, 12 weeks after intervention
Method of measurement
Friedewald formula

8

Description
HDL
Timepoint
before intervention, 12 weeks after intervention
Method of measurement
precipitation

9

Description
HbA1c
Timepoint
before intervention, 12 weeks after intervention
Method of measurement
chromatography

Secondary outcomes

1

Description
Insuline
Timepoint
before intervaention, 12 weeks after intervention
Method of measurement
RIA

2

Description
FBS
Timepoint
before intervaention, 12 weeks after intervention
Method of measurement
enzymatic

Intervention groups

1

Description
Intervention group will receive daily 150 mg CoQ10 as three divided doses for 12 weeks. Each capsule consists of 50 mg CoQ10.
Category
Treatment - Other

2

Description
Placebo group will receive daily three capsules containing corn flour for12 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Institute of Endocrinology and Metabolism, Firouzgar Hospital, Tehran University of Medical Sciences
Full name of responsible person
Dr. Iraj Heidari
Street address
City
Terhran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd, Tehran, Iran
City
Tehran
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, Tehran 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Nutrition, School of Public Health, Teharn University of Medical Sciences
Full name of responsible person
Shima Jazayeri
Position
Assisstant Professor
Other areas of specialty/work
Street address
#60 Alvand Street, Argantin Square
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
sh_jazayeri@tums.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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