Protocol summary
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Study aim
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Determine the effect of myo_inositol supplementation to prevent gestational diabetes in overweight pregnant women.
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Design
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114 pregnant women who are referred to the obstetric clinics are selected. The participants were divided With a block size of 4, into two groups of A and B by selecting the number of (0 - 6) are randomly assigned.
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Settings and conduct
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The participants, if the fasting glucose is less than 92 mg / dl or randomized glucose is less than 200, and other conditions for entry into the study are included.Triglyceride, cholesterol, LDL, HDL, fasting blood sugar , fasting insulin, insulin sensitivity are checked according to routine laboratory tests and then them randomly divided into two groups. In group A (n = 30), people treated with myo-inositol of folic acid once a day from the gestational age of and the group B (n = 30) are received placebo.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Written consent, pregnant women with singleton pregnancy, age above 18 years old, gestational age 14 weeks, per-pregnancy BMI >= 25 and less than 30 kg /m2, fasting glucose less than 92 mg /dL or Random glucose less than 200 mg /dL, no chronic diseases, non-smoking and alcohol.
Exclusion criteria: The death experience of one of the first-degree relatives during pregnancy, treatment with corticosteroid during pregnancy.
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Intervention groups
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Intervention group: Myo-inositol containing 2000 mg of myo-inositol and 200 μg of folic acid (manufactured by the company Lo.Li Pharma ) once a day from the gestational age of 14 weeks to 24 weeks
Control group: Placebo (folic acid powder 400 mcg + wheat flour total 2 grams) once a day from the gestational age 14 weeks to 24 weeks
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Main outcome variables
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primary outcome: Gestational diabetes mellitus (Abnormal oral glucose tolerance test).
Secondary outcomes: Neonatal and pregnancy outcomes and side effect of drug
General information
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Reason for update
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Revising sentence errors
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20160208026446N2
Registration date:
2017-12-14, 1396/09/23
Registration timing:
registered_while_recruiting
Last update:
2019-10-15, 1398/07/23
Update count:
1
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Registration date
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2017-12-14, 1396/09/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Babol University of Medical Sciences,Governmental
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Expected recruitment start date
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2017-12-05, 1396/09/14
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Expected recruitment end date
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2018-12-22, 1397/10/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The Impact of Myo- inositol supplementation to prevent gestational diabetes in overweight pregnant women
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Public title
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The Impact of Myo- inositol supplementation to gestational diabetes in overweight pregnant women
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Conscious written consent
Pregnant women with singleton pregnancy
Age above 18 years old
Gestational age 14 weeks
Pr-pregnancy BMI>= 25 and less than 30 kg / m 2
Fasting glucose less than 92 mg / dL or Random glucose less than 200 mg / dL
No chronic diseases such as diabetes, high blood pressure and cardiovascular disease
Non-smoking and alcohol
Exclusion criteria:
The death experience of one of the first-degree relatives during pregnancy
Treatment with corticosteroids during pregnancy
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Age
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From 18 years old to 45 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Blocked randomization With a block size of 4, for two groups (A, B). Random numbers (0 - 6) was generated using computer software.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Blind groups include: participant, clinical caregiver, researcher, outcome evaluator, data analyst. Double blind study.
Medications and placebo are coded by someone other than the investigator as group (1 and 2) and the investigator do not know which group is related to the drug.
The subjects are satisfied and informed that they may be Instead of medication, placebo is given to them. The distribution method With a block size of 4, for two groups (A, B). Random numbers (0 - 6) was generated using computer software.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-08-20, 1396/05/29
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Ethics committee reference number
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MUBABOL.HRI.REC.1396.82
Health conditions studied
1
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Description of health condition studied
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Diabetes mellitus arising in pregnancy
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ICD-10 code
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O24.9
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ICD-10 code description
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Diabetes mellitus in pregnancy, unspecified
Primary outcomes
1
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Description
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Triglyceride
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Timepoint
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In the second trimester of the week( 24-28 )
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Method of measurement
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Testes based on laboratorial rutine( Detailed description in the proposal)
2
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Description
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Total cholesterol
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Timepoint
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In the second trimester of the week( 24-28 )
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Method of measurement
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Testes based on laboratorial rutine( Detailed description in the proposal)
3
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Description
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LDL
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Timepoint
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In the second trimester of the week( 24-28 )
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Method of measurement
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Testes based on laboratorial rutine( Detailed description in the proposal)
4
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Description
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HDL
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Timepoint
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In the second trimester of the week( 24-28 )
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Method of measurement
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Testes based on laboratorial rutine( Detailed description in the proposal)
5
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Description
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Fasting blood sugar
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Timepoint
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In the second trimester of the week( 24-28 )
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Method of measurement
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Testes based on laboratorial rutine( Detailed description in the proposal)
6
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Description
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Glucose tolerance test of 1 and 2 hours with 75 g of oral glucose
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Timepoint
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In the second trimester of the week( 24-28 )
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Method of measurement
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Testes based on laboratorial rutine( Detailed description in the proposal)
7
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Description
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Fasting insulin
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Timepoint
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In the second trimester of the week( 24-28 )
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Method of measurement
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Testes based on laboratorial rutine( Detailed description in the proposal)
8
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Description
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Insulin sensitivity
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Timepoint
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In the second trimester of the week( 24-28 )
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Method of measurement
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Testes based on laboratorial rutine( Detailed description in the proposal)
Secondary outcomes
1
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Description
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Neonatal and pregnancy outcomes
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Timepoint
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The end of pregnancy for the outcome of pregnancy and infancy
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Method of measurement
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Questionnaire and complete the checklist using patient file
2
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Description
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Side effect of drug
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Timepoint
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In the second trimester of pregnancy (week 24-28) and the third trimester of pregnancy (week 37_38)
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Method of measurement
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Drug side effect Checklist
Intervention groups
1
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Description
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Intervention group: Myoinositol supplementation powder the ino fulic commercial name containing 2000 mg of myoinositol and 200 μg of folic acid (manufactured by the company Lo.Li Pharma ) once a day(one sachet per night in a glass of water is dissolved)
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Category
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Prevention
2
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Description
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: Placebo (folic acid powder 400 mcg + wheat flour total 2 grams) Once a day (one hour a sachet is dissolved in a glass of water) from the gestational age 14 weeks to 24 weeks for a total of 10 weeks . Control group:
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Babol University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable