Efficacy of Myo-inositol in Preventing Gestational Diabetes in High-risk Pregnant Women

AGUNCO Obstetrics and Gynecology Centre

Status and phase: Unknown; Phase 4

Conditions: Gestational Diabetes

Treatments: Drug: Folic Acid; Dietary Supplement: inositol + folic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01511835

MyoIN_diab

Details and patient eligibility

About

The aim of this study is to evaluate the efficacy of myo-inositol in preventing gestational diabetes in high risk pregnant women.

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

60 women in their first trimester of pregnancy affected by one or more of the following risk factors:

• Glycemia levels > 92 mg/dl
• BMI > 30
• At least a parent or a brother (or sister)affected by diabetes
• Pre-existing pregnancy with gestational diabetes

Exclusion criteria

• Pregnant women affected by pregestational diabetes
• Twin pregnancy
• Patients affected by pre-existing diseases in pregnancy (diabetes excluded)
• Patients affected by chronic disorders

Trial design

0 participants in 3 patient groups, including a placebo group

Myo-inositol powder

Experimental group

Treatment:

Dietary Supplement: inositol + folic acid

Dietary Supplement: inositol + folic acid

Myo-inositol soft gel capsules

Experimental group

Treatment:

Dietary Supplement: inositol + folic acid

Dietary Supplement: inositol + folic acid

Folic acid

Placebo Comparator group

Treatment:

Drug: Folic Acid