Myo-inositol Administration in Gestational Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00734448
Recruitment Status : Unknown
Verified June 2014 by Rosario D'anna, University of Messina.
Recruitment status was:  Recruiting
First Posted : August 14, 2008
Last Update Posted : June 13, 2014
Information provided by (Responsible Party):
Rosario D'anna, University of Messina

April 16, 2008
August 14, 2008
June 13, 2014
November 2013
November 2014   (Final data collection date for primary outcome measure)
Insulin sensitivity index (HOMA-IR) and continuous glucose monitoring profile [ Time Frame: Change from baseline in HOMA-IR at 8 weeks of treatment ]
Insulin sensitivity index (HOMA and QUICKI) [ Time Frame: At baseline and after 30 and 60 day of treatment ]
Complete list of historical versions of study NCT00734448 on Archive Site
baby weight at delivery [ Time Frame: After delivery ]
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 ]
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Myo-inositol Administration in Gestational Diabetes
Effect of Myo-inositol Administration on Insulin Sensitivity in Gestational Diabetes Patients by Continuous Glucose Monitoring System (CGMS)
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.
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.
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Gestational Diabetes Mellitus
Dietary Supplement: myo-inositol
2 g twice a day until delivery
Experimental: A,1
Gestational diabetes patients who take myo-inositol
Intervention: Dietary Supplement: myo-inositol
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
December 2014
November 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Gestational diabetes diagnosed within 28 weeks
  • Caucasian pregnant women

Exclusion Criteria:

  • Non Caucasian pregnant women
  • Delivery before 8 weeks of treatment
Sexes Eligible for Study: Female
18 Years to 44 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Rosario D'anna, University of Messina
University of Messina
Not Provided
Principal Investigator: Rosario D'Anna, professor University of Messina, ITALY
University of Messina
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP