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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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 Rosario D'anna, University of Messina:

Primary Outcome Measures:
  • number of gestational diabetes cases diagnosed with OGTT [ Time Frame: 24-28th weeks gestation ]
  • difference in HOMA values [ Time Frame: from first trimester to OGTT ]

Secondary Outcome Measures:
  • incidence of pregnancy complications: hypertension, preterm delivery. macrosomia, shoulder dystocia, etc. [ Time Frame: at delivery ]

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   (Adult)
Sexes 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
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 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

Publications automatically indexed to this study by Identifier (NCT Number):
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

Keywords provided by Rosario D'anna, University of Messina:
gestational diabetes
hypertension in pregnancy

Additional relevant MeSH terms:
Pregnancy Complications
Folic Acid
Vitamin B Complex
Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Growth Substances
Physiological Effects of Drugs processed this record on September 21, 2017