NCT01047982

Myo-inositol in Obese Pregnant Women

Myo-inositol May Prevent Gestational Diabetes in Obese Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: University of Messina · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gestational Diabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	myo-inositol	myo-inositol 2 grams plus folic acid 400 mcg twice a day
OTHER	folic acid 400 mcg	2 pills a day

Timeline

• Start date: 2010-03-01
• Primary completion: 2013-07-01
• Completion: 2013-12-01
• First posted: 2010-01-13
• Last updated: 2014-02-28

Locations

1 site across 1 country: Italy