Myo-inositol, D-chiro-inositol, and D-chiro/Myo-inositol in Gestational Diabetes

Study Overview
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Brief Summary
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Comparison of different inositol stereoisomears in preventing adverse obstetric outcomes in non-obese pregnant women at high risk for gestational diabetes mellitus.

Detailed Description
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The investigators compared outcomes from metabolic and obstetric point of view in GDM pregnant non-obese patient with different stereoisomears of inositol supply. Dietary control and placebo or inositol steroisomears were administered starting at the enrolling time (first fasting oral glucose above 92 mg%; usually before 20 weeks gestations') till the delivery and/or pregnancy end/termination. Oral glucose tolerance test results at 24-28 weeks' gestation was evaluated (as glucose values and oGTT screening). Fetal growth, delivery data, obstetric outcomes and necessity of insulin therapy were taken into account.

Official Title
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Adverse Obstetric Outcomes in Gestational Diabetes Mellitus and Inositol Stereoisomears

Conditions
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GDM

Intervention / Treatment
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* Dietary Supplement: Myo-inositol
* Dietary Supplement: D-chiro-inositol
* Dietary Supplement: D-Chiro / Myo-inositol
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pregnancy below 20 weeks gestation BMI below 30 Fasting glucose between 92 and 126 mg% Singleton pregnancy Naturally conceived Exclusion Criteria: obese patient Fasti g glucose above 126 or below 92

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo control<br>Diet pills of 400 mcg of acid folic daily | Dietary Supplement: Placebo<br>* Dietary control plus folic acid 400 mcg daily<br>|
| D-chiro-inositol / Myo-inositol<br>Diet sachets 2000 mg myo-inositol and 250 mg d-chiro-inositol and 400 mcg folic acid daily | Dietary Supplement: D-Chiro / Myo-inositol<br>* Dietary control Supplementation with myo and d-chiro inositol<br>|
| D-chiro-inositol<br>Diet pills with 500 mg d-chiro-inositol and 400 mcg folic acid daily | Dietary Supplement: D-chiro-inositol<br>* Dietary control plus D-Chiro-Inositol supplementation<br>|
| Myo-inositol<br>Diet sachets with 2000 mg myo-inositol and 200 mcg folic acid twice daily | Dietary Supplement: Myo-inositol<br>* Dietary control plus Myo-inositol<br>* Other names: Supplementation of myo-inositol plus dietary control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OGTT result | OGTT is the mainstay of obstetric outcomes in GDM | 24-28 weeks' gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal measurements at third trimester | Centiles of fetal measurements and amniotic fluid volume | 28 weeks | 
| Delivery data | Gestational age at delivery Route of delivery Fetal gender Fetal weight (grams and centiles) Neonatal hypoglycemia | 25-42 weeks gestations' | 
| Adverse obstetric outcome | Abortion Preterm delivery Polyhydramnios IUGR Macrosomia Fetal distress Preterm delivery pPROM Neonatal morbility (NICU stay, low glucose levels, etc.) Neonatal mortality Cerebral palsy Route of delivery Dystocia Etc. | from first elevated oral fasting glucose (above 92 mg%) till the end/termination of pregnancy (latter 42 weeks gestation) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inositol, GDM