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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
History of Changes
  Purpose

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
Dietary Supplement: inositol + folic acid
Drug: Folic Acid
 Phase 4

Study Type: Interventional

Resource links provided by NLM:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Female
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01511835

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

Locations
Italy
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
  More Information

Publications:

Responsible Party: AGUNCO Obstetrics and Gynecology Centre
ClinicalTrials.gov Identifier: NCT01511835     History of Changes
Other Study ID Numbers: MyoIN_diab
Study First Received: November 16, 2011
Last Updated: January 13, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by AGUNCO Obstetrics and Gynecology Centre:
diabetes
pregnancy
myo-inositol

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Folic Acid
Vitamin B Complex
Inositol
 Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013