Myo-inositol in Obese Pregnant Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rosario D'anna, University of Messina
ClinicalTrials.gov Identifier:
NCT01047982
First received: January 12, 2010
Last updated: February 27, 2014
Last verified: February 2014
  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
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
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: 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

No publications provided

Responsible Party: Rosario D'anna, associate professor, University of Messina
ClinicalTrials.gov 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
macrosomia
hypertension in pregnancy
HOMA-IR
obesity

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

ClinicalTrials.gov processed this record on August 21, 2014