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Myo-inositol in Obese Pregnant Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01047982
First Posted: January 13, 2010
Last Update Posted: February 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rosario D'anna, University of Messina
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01047982


Locations
Italy
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
Investigators
Principal Investigator: Rosario D'Anna, professor University of Messina, ITALY
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rosario D'anna, associate professor, University of Messina
ClinicalTrials.gov Identifier: NCT01047982     History of Changes
Other Study ID Numbers: INOGDM-2010
First Submitted: January 12, 2010
First Posted: January 13, 2010
Last Update Posted: February 28, 2014
Last Verified: February 2014

Keywords provided by Rosario D'anna, University of Messina:
gestational diabetes
macrosomia
hypertension in pregnancy
HOMA-IR
obesity

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