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

G. d'Annunzio University120 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

GDM

Interventions

Myo-inositolDIETARY_SUPPLEMENT

Dietary control plus Myo-inositol

D-chiro-inositolDIETARY_SUPPLEMENT

Dietary control plus D-Chiro-Inositol supplementation

D-Chiro / Myo-inositolDIETARY_SUPPLEMENT

Dietary control Supplementation with myo and d-chiro inositol

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

OGTT result

OGTT is the mainstay of obstetric outcomes in GDM

Time frame: 24-28 weeks' gestation

Secondary Outcomes

Fetal measurements at third trimester

Centiles of fetal measurements and amniotic fluid volume

Time frame: 28 weeks

Delivery data

Gestational age at delivery Route of delivery Fetal gender Fetal weight (grams and centiles) Neonatal hypoglycemia

Time frame: 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.

Time frame: from first elevated oral fasting glucose (above 92 mg%) till the end/termination of pregnancy (latter 42 weeks gestation)

Data from ClinicalTrials.gov

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