Myo-inositol in Obese Pregnant Women

University of Messina

Status: Completed

Conditions: Gestational Diabetes

Treatments: Other: folic acid 400 mcg; Dietary Supplement: myo-inositol

Study type: Interventional

Funder types: Other

Identifiers

NCT01047982

INOGDM-2010

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 2 patient groups, including a placebo group

myo-inositol

Active Comparator group

Treatment:

Dietary Supplement: myo-inositol

placebo

Placebo Comparator group

Description:

acid folic 400 mcg twice per day

Treatment:

Other: folic acid 400 mcg