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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by AGUNCO Obstetrics and Gynecology Centre.
Recruitment status was  Recruiting
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
  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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 22, 2014