Efficacy of Myo-inositol in Preventing Gestational Diabetes in High-risk Pregnant Women

This study is currently recruiting participants.
Verified January 2012 by AGUNCO Obstetrics and Gynecology Centre
Sponsor:
Information provided by (Responsible Party):
AGUNCO Obstetrics and Gynecology Centre
ClinicalTrials.gov Identifier:
NCT01511835
First received: November 16, 2011
Last updated: January 13, 2012
Last verified: January 2012

November 16, 2011
January 13, 2012
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OGTT
The diagnostic 75g oral glucose tolerance test (OGTT) is performed between 24 and 28 weeks of gestation.
Same as current
Complete list of historical versions of study NCT01511835 on ClinicalTrials.gov Archive Site
  • Number of pregnant women with gestational diabetes
  • Number of pregnant women requiring insulin treatment
  • Weight gain at the end of pregnancy
  • Number of newborn infants whose weight is more than 4000 g
  • Number of newborn infants requiring Neonatal Intensive Care (NIC)
Same as current
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Efficacy of Myo-inositol in Preventing Gestational Diabetes in High-risk Pregnant Women
Not Provided

The aim of this study is to evaluate the efficacy of myo-inositol in preventing gestational diabetes in high risk pregnant women.

Not Provided
Interventional
Phase 4
Not Provided
Gestational Diabetes
  • Dietary Supplement: inositol + folic acid
    2000 mg of inositol+200mcg of folic acid; 2 per diem
  • Dietary Supplement: inositol + folic acid
    600 mg of inositol + 200mcg of folic acid; 2 cp per diem
  • Drug: Folic Acid
    Folic Acid 400mcg; 1 cp/die
  • Experimental: Myo-inositol powder
    Intervention: Dietary Supplement: inositol + folic acid
  • Experimental: Myo-inositol soft gel capsules
    Intervention: Dietary Supplement: inositol + folic acid
  • Placebo Comparator: Folic acid
    Intervention: Drug: Folic Acid

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
Not Provided
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Inclusion Criteria:

60 women in their first trimester of pregnancy affected by one or more of the following risk factors:

  • Glycemia levels > 92 mg/dl
  • BMI > 30
  • At least a parent or a brother (or sister)affected by diabetes
  • Pre-existing pregnancy with gestational diabetes

Exclusion Criteria:

  • Pregnant women affected by pregestational diabetes
  • Twin pregnancy
  • Patients affected by pre-existing diseases in pregnancy (diabetes excluded)
  • Patients affected by chronic disorders
Female
20 Years to 45 Years
Not Provided
Contact: Vittorio Unfer vunfer@gmail.com
Contact: Gianfranco Carlomagno gianfranco.carlomagno@agunco.it
Italy
 
NCT01511835
MyoIN_diab
Not Provided
AGUNCO Obstetrics and Gynecology Centre
AGUNCO Obstetrics and Gynecology Centre
Not Provided
Not Provided
AGUNCO Obstetrics and Gynecology Centre
January 2012

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