Myo-inositol Administration in Gestational Diabetes
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 30
- Gestational diabetes diagnosed within 28 weeks
- Caucasian pregnant women
- 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
Related Research Topics
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Trial Locations
- Locations (1)
University of Messina -
🇮🇹Messina, Sicilia, Italy
University of Messina -🇮🇹Messina, Sicilia, Italyfrancesco corrado, researcherSub Investigatorrosario d'anna, professorPrincipal Investigator