NCT01762826

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

Adverse Obstetric Outcomes in Gestational Diabetes Mellitus and Inositol Stereoisomears

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: G. d'Annunzio University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• GDM

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Myo-inositol	Dietary control plus Myo-inositol
DIETARY_SUPPLEMENT	D-chiro-inositol	Dietary control plus D-Chiro-Inositol supplementation
DIETARY_SUPPLEMENT	D-Chiro / Myo-inositol	Dietary control Supplementation with myo and d-chiro inositol
DIETARY_SUPPLEMENT	Placebo	Dietary control plus folic acid 400 mcg daily

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-04-01
• Completion: 2013-09-01
• First posted: 2013-01-08
• Last updated: 2013-01-08