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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. From literature, the investigators know that myo-inositol positively affects insulin resistance in polycystic ovary syndrome patients restoring spontaneous ovarian activity. So the investigators hypothesize that the administration of 2 g, twice a day, would improve the insulin-receptor activity also in pregnant women affected by gestational diabetes.
Our study is a randomized, prospective, controlled trial, including all consecutive Caucasian gestational diabetes patients diagnosed,according the Carpenter's criteria, from April to December 2008 in the Department of Obstetric and Gynecology fo University of Messina. After an informed consent they will be enrolled in the study and myo-inositol, combined with folic acid, will be administered 2 g twice a day.
The insulin sensitivity index (HOMA and QUICKI) will be checked at baseline (fasting GTT at 26-28 weeks) and after 30 and 60 days of treatment. Cardiovascular risk profile, obstetric outcome and dosage of insulin therapy will be registered. The pregnant women who will delivery before 36 weeks of gestation will be excluded.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care
Gestational Diabetes Mellitus
University of Messina - Dept. Obstetrics and Gynecology
University of Messina
Published on BioPortfolio: 2014-07-23T21:20:47-0400
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Diabetes mellitus induced by PREGNANCY but resolved at the end of pregnancy. It does not include previously diagnosed diabetics who become pregnant (PREGNANCY IN DIABETICS). Gestational diabetes usually develops in late pregnancy when insulin antagonistic hormones peaks leading to INSULIN RESISTANCE; GLUCOSE INTOLERANCE; and HYPERGLYCEMIA.
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