Myo-inositol in Obese Pregnant Women

University of Messina220 enrolled

Overview

Myo-Inositol is classified as a member of the vitamin B complex. It is a constituent of living cells and is widespread in many food. It is involved in a number of biological processes, including insulin signal transduction, resulting in modulating insulin sensitivity. This is a prospective, randomized, double center, placebo-controlled study. Two hundred and twenty obese pregnant women will be included in the trial and, after an informed consent, will assume randomly 2 g of myo-inositol twice a day or placebo from 12-13th weeks gestation until delivery. Then,they will perform an Oral Glucose Tolerance Test (OGTT) at 24-28th weeks gestation. Records about delivery (gestational age, neonatal weight...) will be registered.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

220

Conditions

Gestational Diabetes

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Obese pregnant women: BMI \> 30 Kg/cm2 * first trimester fast glycaemia \< 126 mg/dl * single pregnancy Exclusion Criteria: * Pregnant women with BMI \< 30 Kg/cm2 * first trimester fast glycaemia \> 126 mg/dl * previous gestational diabetes * twin pregnancy * pregestational diabetes * associated therapies with corticosteroids

Outcomes

Primary Outcomes

number of gestational diabetes cases diagnosed with OGTT

Time frame: 24-28th weeks gestation

difference in HOMA values

Time frame: from first trimester to OGTT

Secondary Outcomes

incidence of pregnancy complications: hypertension, preterm delivery. macrosomia, shoulder dystocia, etc.

Time frame: at delivery