Myo-inositol in Obese Pregnant Women

Not Applicable

Completed

• Conditions: Gestational Diabetes
• Interventions: Dietary Supplement: myo-inositol; Other: folic acid 400 mcg

• Registration Number: NCT01047982
• Lead Sponsor: University of Messina

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-12
• Study First Submitted QC: 2010-01-12
• Study First Posted: 2010-01-13
• Study Start: 2010-03
• Primary Completion: 2013-07
• Study Completion: 2013-12
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-27
• Last Update Posted: 2014-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
myo-inositol	myo-inositol	-
placebo	folic acid 400 mcg	acid folic 400 mcg twice per day

Primary Outcome Measures

Name	Time	Method
number of gestational diabetes cases diagnosed with OGTT	24-28th weeks gestation
difference in HOMA values	from first trimester to OGTT

Secondary Outcome Measures

Name	Time	Method
incidence of pregnancy complications: hypertension, preterm delivery. macrosomia, shoulder dystocia, etc.	at delivery

Trial Locations

Locations (1)

Obstetrics and Gynecology Unit, University of Messina and Obstetrics and Gynecology Unit of Modena University; 🇮🇹 Messina and Modena, Italy