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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by AGUNCO Obstetrics and Gynecology Centre.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
AGUNCO Obstetrics and Gynecology Centre Identifier:
First received: November 16, 2011
Last updated: January 13, 2012
Last verified: January 2012
The aim of this study is to evaluate the efficacy of myo-inositol in preventing gestational diabetes in high risk pregnant women.

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

Study Type: Interventional

Resource links provided by NLM:

Further study details as provided by AGUNCO Obstetrics and Gynecology Centre:

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

Secondary Outcome Measures:
  • 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)

Arms Assigned Interventions
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


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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01511835

Contact: Vittorio Unfer
Contact: Gianfranco Carlomagno

AGUNCO Recruiting
Rome, Italy, 00155
Contact: Gianfranco Carlomagno   
Principal Investigator: Vittorio Unfer         
Principal Investigator: Gianfranco Carlomagno         
Sponsors and Collaborators
AGUNCO Obstetrics and Gynecology Centre
  More Information

Responsible Party: AGUNCO Obstetrics and Gynecology Centre Identifier: NCT01511835     History of Changes
Other Study ID Numbers: MyoIN_diab
Study First Received: November 16, 2011
Last Updated: January 13, 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
Hematinics processed this record on May 25, 2017