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

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.
ClinicalTrials.gov Identifier: NCT01511835
Recruitment Status : Unknown
Verified January 2012 by AGUNCO Obstetrics and Gynecology Centre.
Recruitment status was:  Recruiting
First Posted : January 19, 2012
Last Update Posted : January 19, 2012
Information provided by (Responsible Party):
AGUNCO Obstetrics and Gynecology Centre

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

Condition or disease Intervention/treatment Phase
Gestational Diabetes Dietary Supplement: inositol + folic acid Drug: Folic Acid Phase 4

Study Type : Interventional  (Clinical Trial)

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Folic Acid
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Myo-inositol powder Dietary Supplement: inositol + folic acid
2000 mg of inositol+200mcg of folic acid; 2 per diem
Experimental: Myo-inositol soft gel capsules Dietary Supplement: inositol + folic acid
600 mg of inositol + 200mcg of folic acid; 2 cp per diem
Placebo Comparator: Folic acid Drug: Folic Acid
Folic Acid 400mcg; 1 cp/die

Primary Outcome Measures :
  1. OGTT
    The diagnostic 75g oral glucose tolerance test (OGTT) is performed between 24 and 28 weeks of gestation.

Secondary Outcome Measures :
  1. Number of pregnant women with gestational diabetes
  2. Number of pregnant women requiring insulin treatment
  3. Weight gain at the end of pregnancy
  4. Number of newborn infants whose weight is more than 4000 g
  5. Number of newborn infants requiring Neonatal Intensive Care (NIC)

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511835

Contact: Vittorio Unfer vunfer@gmail.com
Contact: Gianfranco Carlomagno gianfranco.carlomagno@agunco.it

AGUNCO Recruiting
Rome, Italy, 00155
Contact: Gianfranco Carlomagno       gianfranco.carlomagno@agunco.it   
Principal Investigator: Vittorio Unfer         
Principal Investigator: Gianfranco Carlomagno         
Sponsors and Collaborators
AGUNCO Obstetrics and Gynecology Centre

Responsible Party: AGUNCO Obstetrics and Gynecology Centre
ClinicalTrials.gov Identifier: NCT01511835     History of Changes
Other Study ID Numbers: MyoIN_diab
First Posted: January 19, 2012    Key Record Dates
Last Update Posted: January 19, 2012
Last Verified: January 2012

Keywords provided by AGUNCO Obstetrics and Gynecology Centre:

Additional relevant MeSH terms:
Diabetes, Gestational
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Folic Acid
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs