Objectives: Determining the effect of ubiquinone on inflammation and oxidative stress status among type 2 diabetes patients with coronary heart disease. Design: Parallel double-blind randomized controlled clinical trial.Inclusion Criteria: Subjects with 45-75 years old، diagnosed with type 2 diabetes with coronary heart disease . Exclusion Criteria:Patients who do not want to cooperate؛ diabetic patients who have others complications associated with diabetes such as: kidney disease؛ neuropathy and retinopathy؛ patients with hypo and/or hyperthyroidism are excluded from this study. Population and sample size: 60 subjects with coronary heart disease, eligible and referred to Shahid Beheshti hospital affiliated to Kashan University of Medical Sciences, Kashan, Iran. in the study will be selected. Intervention: Patients will be assigned to receive either 100 mg Q10 supplements (intervention group: n=30) or placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 8-wk intervention to evaluate lipoprotein a (Lp(a)), status of inflammation and oxidative stress. Start and End Date of Intervention: 8 weeks (May 4, 2015-Jul 5, 2015). Outcomes: Advance glycation End Products (AGEs), Inflamatory Factor IL-9, status of oxidative stress such as Protein carbonyl, and MDA will be measured at baseline and end-of-trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014111920007N1
Registration date:2015-06-09, 1394/03/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-09, 1394/03/19
Registrant information
Name
Seyyed Mehdi Mirhashemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5562 0608
Email address
mirhashemi@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical SciencesKashan University of Medical Sciences,
Expected recruitment start date
2015-05-04, 1394/02/14
Expected recruitment end date
2015-05-10, 1394/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Ubiquinone on inflammation and oxidative stress status among type 2 diabetes patients with coronary heart disease
Public title
Effect of Ubiquinone on diabetes with coronary heart disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Subjects with 45-75 years old؛ diagnosed with type 2 diabetes with coronary heart disease .
Exclusion Criteria:Patients who do not want to corporate؛ Diabetic patients who have others complications associated with diabetes such as: kidney disease؛ neuropathy and retinopathy؛ Patients with hypo and/or hyperthyroidism are excluded from this study.
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:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomized Numbers Table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan Unversity of Medical Sciences