Protocol summary

Summary
Objectives: The aim of this study is to determine the Effects of Q10 supplementation on serum some biochemical variables in patients with type 2 diabetes. Design: In this double blind study, a total number of 70 patients will be selected. They will be divided into two groups of intervention (coenzyme Q10) and control (placebo) by simple random sampling. They will be matched in age and BMI. The endocrinologist, pharmacy and the participants will be blinded to the study interventions. Setting and conduct: The aim and procedures of the study will be conveyed to the participants and written informed consent will be obtain from each of them. Major Inclusion and Exclusion criteria: Major inclusion criteria are Type 2 diabetic patients for more than 2 years and not consumption of vitamin and mineral supplements during the last three months. Major Exclusion criteria are changing in dosage of glucose lowering medications, physical activity and diet during the intervention. Intervention: One group will receive coenzyme Q10 (one 100 mg capsule for 12 weeks) and the other group will receive placebo capsule containing cellulose acetate for the same dosage and period. Main outcome measures (variables): Serum levels of glucose, hemoglobin A1c, insulin, cholesterol, triglyceride, HDL-C, LDL-C, hs-CRP, Q10, gamma glutamyl transferase, pseudo cholinesterase, bilirubin and ferritin will be measured at the beginning and at the end of the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016011125949N1
Registration date: 2016-01-30, 1394/11/10
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-01-30, 1394/11/10
Registrant information
Name
Ali Khosrowbeygi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3638
Email address
a.khosrowbeygi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2016-03-01, 1394/12/11
Expected recruitment end date
2016-07-02, 1395/04/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Q10 supplementation on serum levels of gamma glutamyl transferase, pseudo cholinesterase, bilirubin, ferritin and C-reactive protein in patients with type II diabetes
Public title
Benefits of Q10 supplementation in patients with type II diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Type 2 diabetic patients for more than 2 years and not consumption of vitamin and mineral supplements during the last three months. Exclusion criteria: changing in dosage of glucose lowering medications; physical activity and diet during the intervention; any chronic renal; hepatic; thyroid; haematic and gastrointestinal disorders; using anticoagulants; diuretics and β blockers; hormone therapy; insulin therapy; alcoholism; smoking; pregnancy and lactation.
Age
From 30 years old to 65 years old
Gender
Female
Phase
2-3
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
Randomization will be done using simple random sampling method.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Sardasht, Arak University of Medical Sciences, Arak
City
Arak
Postal code
Approval date
2015-12-21, 1394/09/30
Ethics committee reference number
IR.ARAKMU.REC.1394.251

Health conditions studied

1

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

Primary outcomes

1

Description
Fasting glucose
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Colorimetric

2

Description
Fasting insulin
Timepoint
Before and after 12 weeks of intervention
Method of measurement
ELISA

3

Description
HbA1C
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Chromatoghraphy

4

Description
HDL-C
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Colorimetric

5

Description
TG
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Colorimetric

6

Description
TC
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Colorimetric

7

Description
LDL-C
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Friedewald’s equation

8

Description
Q10
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Chromatoghraphy

9

Description
Gamma glutamyl transferase
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Colorimetric

10

Description
Bilirubin
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Colorimetric

11

Description
Ferritin
Timepoint
Before and after 12 weeks of intervention
Method of measurement
ELISA

12

Description
hs-CRP
Timepoint
Before and after 12 weeks of intervention
Method of measurement
ELISA

13

Description
Pseudo cholinesterase
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Colorimetric

Secondary outcomes

1

Description
Blood pressure
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Barometer

2

Description
waist circumference
Timepoint
Before and after 12 weeks of intervention
Method of measurement
tape measure

3

Description
BMI
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Formula

Intervention groups

1

Description
One capsule coenzyme Q10 (100 mg) per day for 12 weeks.
Category
Treatment - Drugs

2

Description
One capsule placebo cellulose acetate (100 mg) per day for 12 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Mahsa Gholami
Street address
Basij Square, Sardasht, Amiralmomenin Hospital, Arak
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Arak University of Medical Sciences
Full name of responsible person
Dr. Ali Ghazavi
Street address
Basij Square, Sardasht, Arak University of Medical Sciences, Arak
City
Arak
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 of Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr. Ali Khosrowbeygi
Position
PhD
Other areas of specialty/work
Street address
Basij Square, Sardasht, Department of Biochemistry, School of Medicine, Arak University of Medical Sciences, Arak
City
Arak
Postal code
Phone
+98 86 3417 3501
Fax
Email
a.khosrowbeygi@arakmu.ac.ir; khosrowbeygi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Ali Khosrowbeygi
Position
PhD
Other areas of specialty/work
Street address
Basij Square, Sardasht, Department of Biochemistry, School of Medicine, Arak University of Medical Sciences, Arak
City
Arak
Postal code
Phone
+98 86 3417 3501
Fax
Email
a.khosrowbeygi@arakmu.ac.ir; khosrowbeygi@yahoo.com
Web page address

Person responsible for updating data

Contact

Sharing plan

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