Myo-inositol in Obese Pregnant Women

Gestational Diabetes Clinical Trial

Official title:

Myo-inositol May Prevent Gestational Diabetes in Obese Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01047982
• Other study ID #: INOGDM-2010
• Status: Completed
• Phase: N/A
• First received: January 12, 2010
• Last updated: February 27, 2014
• Start date: March 2010
• Est. completion date: December 2013

Study information

• Verified date: February 2014
• Source: University of Messina
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: December 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Intervention

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

Locations

Country	Name	City	State
Italy	Obstetrics and Gynecology Unit, University of Messina and Obstetrics and Gynecology Unit of Modena University	Messina and Modena

Sponsors (1)

Lead Sponsor	Collaborator
University of Messina

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of gestational diabetes cases diagnosed with OGTT		24-28th weeks gestation	No
Primary	difference in HOMA values		from first trimester to OGTT	No
Secondary	incidence of pregnancy complications: hypertension, preterm delivery. macrosomia, shoulder dystocia, etc.		at delivery	No