Determination of the Effect of Co-Enzyme Q10 Supplementation on Glycemic Index, Lipid Profile, and Inflammatory Indicator in Gestational Gestational Patients in a Randomized Clinical Trial
Design
Clinical trials with control group, with parallel groups, blind, randomized. Random sequences will be generated using the Random Generator program.
Settings and conduct
This study is done at al-Zahra hospital in Shiraz. After identifying eligible people according to entry and exit criteria, in the first visit, the purpose and stages of the study are fully described to individuals, and if they so desire, they will be required to complete the written consent form. Subsequently, for each person, the general information form is completed. Patients will be assigned randomly into two groups of placebo and 200 mg coenzyme Q10 supplement. The duration of the intervention is also one month
Participants/Inclusion and exclusion criteria
inclusion criteria: Age between 40 and 18 years old Pregnant women whose blood glucose levels at 24-24 weeks of gestation have any of the following criteria based on the 2014 American Diabetes Association's 2014 guide, are considered as gestational diabetes: fasting plasma glucose (FPG) ≥ 92 mg / dl; tolerance testing Oral glucose with 75 g glucose 1 hour (1-hOGTT) ≥180 mg / dl; Oral glucose tolerance test 75 g Glucose 2 hours (2-hOGTT) ≥ 153 mg / dl Individuals completing and delivering the informed consent form of the study. exclusion criteria:The sudden separation of the placenta from the fetus Premature rupture of amniotic sac Preeclampsia and eclampsia Hypo or hyperthyroidism History of any type of diabetes smoking Liver and kidney disease Taking antibiotics or glucocorticoids Treated with insulin.
Intervention groups
Control group: receiving placebo. Intervention group: receiving Co Q10 supplementation.
Main outcome variables
Blood sugar level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080910001233N4
Registration date:2019-04-18, 1398/01/29
Registration timing:registered_while_recruiting
Last update:2019-04-18, 1398/01/29
Update count:0
Registration date
2019-04-18, 1398/01/29
Registrant information
Name
Maryam Asgharnia
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
asgharnia@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-17, 1398/01/28
Expected recruitment end date
2019-05-20, 1398/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of coenzyme Q10 supplementation on glycemic index, lipid profile and inflammatory markers in women with gestational diabetes
Public title
Effect of Coenzyme Q10 Supplementation on Gestational Diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 40 and 18 years old
fasting plasma glucose (FBS) ≥ 92 mg / dl
tolerance testing Oral glucose with 75 g glucose 1 hour (1-hOGTT) ≥180 mg / dl
Oral glucose tolerance test 75 g Glucose 2 hours (2-hOGTT) ≥ 153 mg / dl
Individuals completing and delivering the informed consent form of the study.
Exclusion criteria:
The sudden separation of the placenta from the fetus
Preeclampsia
Eclampsia
Hypothyroidism
hyperthyroidism
History of any type of diabetes
smoking
Liver disease
kidney disease
Taking antibiotics
Taking glucocorticoids
Treated with insulin
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random sequences will be generated using the Random Generator program. Based on the random block method and considering the four blocks, 15 blocks will be generated for 60 patients. After generating the list, each person will be assigned a dedicated code and will be recognized by the person during the study with this code
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and researchers will be blinded by supplementation with the same package.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Research vice-chancellorship Building, in front of 17-Shahrivar Hospital, ShahidSiadati St., Namjoo Ave., Rasht, Guilan, IRAN
City
Rasht
Province
Guilan
Postal code
41446-66949
Approval date
2019-02-23, 1397/12/04
Ethics committee reference number
IR.GUMS.REC.1397.454
Health conditions studied
1
Description of health condition studied
Gestational Diabetes
ICD-10 code
o24.4
ICD-10 code description
Gestational diabetes mellitus NOS
Primary outcomes
1
Description
Blood sugar level
Timepoint
Before intervention, after intervention
Method of measurement
Colorimetric method
Secondary outcomes
1
Description
HDL-C
Timepoint
Before intervention, after intervention
Method of measurement
Colorimetric method
Intervention groups
1
Description
Intervention group: Intervention group: Take 200 milligrams of daily supplementation of coenzyme Q10
Category
Treatment - Other
2
Description
Control group: Placebo contains cellulose every day