Objectives: The aim of this study is to determine the effects of Q10 supplementation on serum biochemical variables in patients with type 2 diabetes. Design: In this double blind study a total number of 68 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 obtained from each of them. Major Inclusion and Exclusion criteria: Major inclusion criteria are patients with type 2 diabetic 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 with the same dosage and period. Main outcome measures (variables): Serum levels of glucose, hemoglobin A1c, insulin, leptin, adiponectin, 8-isoprostane malodialdehyde will be measured at the beginning and at the end of the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016081525949N3
Registration date:2016-08-27, 1395/06/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-27, 1395/06/06
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
2016-07-26, 1395/05/05
Expected recruitment end date
2016-10-26, 1395/08/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of coenzyme Q10 supplementation on serum adiponectin-to-leptin ratio, 8-isoprostane and malondialdehyde in female patients with type 2 diabetes
Public title
Effects of Q10 supplementation in type II diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients that have been suffered type 2 diabetes for more than 2 years and that have not consumed 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; hormone therapy; insulin therapy; alcoholism; smoking; pregnancy; lactation and using anticoagulants, diuretics and β blockers.
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:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The patients will be divided into intervention and control groups by simple random sampling.
Secondary Ids
empty
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
2016-07-25, 1395/05/04
Ethics committee reference number
IR.ARAKMU.REC.1395.158
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
HbA1C
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Chromatoghraphy
3
Description
Fasting insulin
Timepoint
Before and after 12 weeks of intervention
Method of measurement
ELISA
4
Description
Coenzyme Q10
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Chromatoghraphy
5
Description
Leptin
Timepoint
Before and after 12 weeks of intervention
Method of measurement
ELISA
6
Description
Adiponectin
Timepoint
Before and after 12 weeks of intervention
Method of measurement
ELISA
7
Description
8-isoprostane
Timepoint
Before and after 12 weeks of intervention
Method of measurement
ELISA
8
Description
Malondialdehyde
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Spectrophotometric
Secondary outcomes
1
Description
BMI
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Formula
Intervention groups
1
Description
Control group: One capsule placebo cellulose acetate (100 mg) per day for 12 weeks.
Category
Placebo
2
Description
Intervention group: One capsule coenzyme Q10 (100 mg) per day for 12 weeks.