Myo-inositol in Obese Pregnant Women

This study has been completed.
Information provided by (Responsible Party):
Rosario D'anna, University of Messina Identifier:
First received: January 12, 2010
Last updated: February 27, 2014
Last verified: February 2014

Myo-Inositol is classified as a member of the vitamin B complex. It is a constituent of living cells and is widespread in many food. It is involved in a number of biological processes, including insulin signal transduction, resulting in modulating insulin sensitivity. This is a prospective, randomized, double center, placebo-controlled study. Two hundred and twenty obese pregnant women will be included in the trial and, after an informed consent, will assume randomly 2 g of myo-inositol twice a day or placebo from 12-13th weeks gestation until delivery. Then,they will perform an Oral Glucose Tolerance Test (OGTT) at 24-28th weeks gestation. Records about delivery (gestational age, neonatal weight...) will be registered.

Condition Intervention
Gestational Diabetes
Dietary Supplement: myo-inositol
Other: folic acid 400 mcg

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Myo-inositol May Prevent Gestational Diabetes in Obese Women

Resource links provided by NLM:

Further study details as provided by University of Messina:

Primary Outcome Measures:
  • number of gestational diabetes cases diagnosed with OGTT [ Time Frame: 24-28th weeks gestation ] [ Designated as safety issue: No ]
  • difference in HOMA values [ Time Frame: from first trimester to OGTT ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • incidence of pregnancy complications: hypertension, preterm delivery. macrosomia, shoulder dystocia, etc. [ Time Frame: at delivery ] [ Designated as safety issue: No ]

Enrollment: 220
Study Start Date: March 2010
Study Completion Date: December 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: myo-inositol Dietary Supplement: myo-inositol
myo-inositol 2 grams plus folic acid 400 mcg twice a day
Placebo Comparator: placebo
acid folic 400 mcg twice per day
Other: folic acid 400 mcg
2 pills a day


Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Obese pregnant women: BMI > 30 Kg/cm2
  • first trimester fast glycaemia < 126 mg/dl
  • single pregnancy

Exclusion Criteria:

  • Pregnant women with BMI < 30 Kg/cm2
  • first trimester fast glycaemia > 126 mg/dl
  • previous gestational diabetes
  • twin pregnancy
  • pregestational diabetes
  • associated therapies with corticosteroids
  Contacts and Locations
Please refer to this study by its identifier: NCT01047982

Obstetrics and Gynecology Unit, University of Messina and Obstetrics and Gynecology Unit of Modena University
Messina and Modena, Italy
Sponsors and Collaborators
University of Messina
Principal Investigator: Rosario D'Anna, professor University of Messina, ITALY
  More Information

No publications provided

Responsible Party: Rosario D'anna, associate professor, University of Messina Identifier: NCT01047982     History of Changes
Other Study ID Numbers: INOGDM-2010
Study First Received: January 12, 2010
Last Updated: February 27, 2014
Health Authority: Italy: Ministry of Health

Keywords provided by University of Messina:
gestational diabetes
hypertension in pregnancy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Folic Acid
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses processed this record on April 23, 2014