Clinical Trial: Myo-inositol Administration in Gestational Diabetes

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary: 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.
Sponsor: University of Messina

Current Primary Outcome: Insulin sensitivity index (HOMA-IR) and continuous glucose monitoring profile [ Time Frame: Change from baseline in HOMA-IR at 8 weeks of treatment ]

Original Primary Outcome: Insulin sensitivity index (HOMA and QUICKI) [ Time Frame: At baseline and after 30 and 60 day of treatment ]

Current Secondary Outcome: baby weight at delivery [ Time Frame: After delivery ]

Original Secondary Outcome: Cardiovascular risk profile (serum lipoproteins, PCR, adiponectin and TNF-alfa), obstetric outcome (hypertensive disorders, macrosomia, cesarean section, neonatal hypoglycemia and jaundice requiring phototherapy) and dosage of insulin therapy. [ Time Frame: At baseline and after 30 and 60 days of treatment ]

Information By: University of Messina

Dates:
Date Received: April 16, 2008
Date Started: November 2013
Date Completion: December 2014
Last Updated: June 12, 2014
Last Verified: June 2014