Myo-Inositol Administration in Gestational Diabetes
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
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00734448
- Information obtained from ClinicalTrials.gov on July 15, 2010
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Medical and Biotech [MESH] Definitions
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.
A condition of fetal overgrowth leading to a large-for-gestational-age FETUS. It is defined as BIRTH WEIGHT greater than 4,000 grams or above the 90th percentile for population and sex-specific growth curves. It is commonly seen in GESTATIONAL DIABETES; PROLONGED PREGNANCY; and pregnancies complicated by pre-existing diabetes mellitus.
The state of PREGNANCY in women with DIABETES MELLITUS. This does not include either symptomatic diabetes or GLUCOSE INTOLERANCE induced by pregnancy (DIABETES, GESTATIONAL) which resolves at the end of pregnancy.
A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.
Diabetes mellitus induced experimentally by administration of various diabetogenic agents or by PANCREATECTOMY.