Clinical trial of the effect of inofolic supplementation compared with metformin on metabolic profiles and gene expression related to insulin and lipid in women with polycystic ovary syndrome
Objective: The aim of this study is to determine the effects of inofolic supplementation on metabolic profiles and gene expression related to insulin and lipid in patients with polycystic ovary syndrome (PCOS). Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with PCOS according to Rotterdam criteria aged 18 to 40 years. Exclusion criteria: Unwillingness to cooperate. Population and sample size: Among patients with PCOS referred to Kosar Clinic affiliated to Arak University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Intervention: Patients will be assigned into two groups to receive inofolic (n=30) or metformin (n=30). Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and end of the intervention: 12 weeks. Outcomes: markers of insulin metabolism (primary outcomes), lipid profiles, and gene expression related to insulin and lipid (secondary outcome) will be quantified at study baseline and end-of-trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017082733941N10
Registration date:2017-09-18, 1396/06/27
Registration timing:retrospective
Last update:
Update count:1
Registration date
2017-09-18, 1396/06/27
Registrant information
Name
Mohammadreza Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
ostadmohammadi-vr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2017-08-15, 1396/05/24
Expected recruitment end date
2017-08-30, 1396/06/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of inofolic supplementation compared with metformin on metabolic profiles and gene expression related to insulin and lipid in women with polycystic ovary syndrome
Public title
Effect of inofolic supplementation in treatment of women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with PCOS according to Rotterdam criteria; aged 18 to 40 years. Exclusion criteria: Unwillingness to cooperate.
Age
From 18 years old to 40 years old
Gender
Female
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Vice chancellor for research, Arak University of Medical Sciences
City
Arak
Postal code
Approval date
2017-08-14, 1396/05/23
Ethics committee reference number
IR.ARAKMU.REC.1396.90
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
2
Description
Insulin resistance
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Calculation using HOMA formula
Secondary outcomes
1
Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
2
Description
HDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
Expressed levels of PPAR-γ gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
5
Description
Expressed levels of GLUT-1 gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
6
Description
Expressed levels of Lp(a) gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
7
Description
Expressed levels of Ox-LDL gene
Timepoint
At the beginning of the study and after 12 weeks of intervention