Myo-inositol Administration in Gestational Diabetes

Gestational Diabetes Mellitus Clinical Trial

Official title: Effect of Myo-inositol Administration on Insulin Sensitivity in Gestational Diabetes Patients by Continuous Glucose Monitoring System (CGMS)

Status Recruiting

Clinical Trial Summary

Myo-Inositol is an insulin sensitizing agent that ameliorate the insulin resistance in women affected by gestational diabetes (GDM), but there is no information about the effect on the glucose profile. Maternal hyperglycemia of GDM, especially hypoglycemic excursions, are associated with adverse pregnancy outcome. Continuous Glucose Monitoring System (CGMS) is obviously better than intermittent self monitoring in detecting glucose profile and magnitude and duration of glucose fluctuations. For this reason, we propose a clinical trial to analyze the characteristics of glucose variability in GDM women,treated with diet and folic acid alone or with diet, folic acid and myo-inositol supplementation.

Clinical Trial Description

Our study is a randomized, prospective, controlled trial, including the first 30 consecutive Caucasian gestational diabetes patients diagnosed,according the International Association of Diabetes and Pregnancy Study Group (IADPSG) panel criteria, from November 2013 in the Department of Obstetric and Gynecology of Messina University (ITALY). After an informed consent they will be randomly assigned to receive (n. 15) diet and folic acid (400 mcg per day) alone or (n. 15) diet, folic acid (400 mcg per day) and myo-inositol (2 g. twice a day)supplementation. The insulin sensitivity index (HOMA-IR) and the glycemic profile will be monitor by CGMS for each patient at GDM diagnosis and after 8 weeks of treatment The pregnant women who will delivery before the time treatment (8 weeks) or who need insulin will be excluded. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

• NCT number: NCT00734448
• Study type: Interventional
• Source: University of Messina
• Contact: rosario d'anna, professor
• Phone: 39-090-2211
• Email: rosariodanna@tin.it
• Status: Recruiting
• Phase: N/A
• Start date: November 2013
• Completion date: December 2014