Myo-inositol Administration in Gestational Diabetes

Not Applicable

• Conditions: Gestational Diabetes Mellitus

• Registration Number: NCT00734448
• Lead Sponsor: University of Messina

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2008-04-16
• Study First Submitted QC: 2008-08-13
• Study First Posted: 2008-08-14
• Study Start: 2013-11
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-12
• Last Update Posted: 2014-06-13
• Primary Completion: 2014-11
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Gestational diabetes diagnosed within 28 weeks
• Caucasian pregnant women

Exclusion Criteria

• Non Caucasian pregnant women
• Delivery before 8 weeks of treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity index (HOMA-IR) and continuous glucose monitoring profile	Change from baseline in HOMA-IR at 8 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
baby weight at delivery	After delivery

Trial Locations

Locations (1)

University of Messina -; 🇮🇹 Messina, Sicilia, Italy