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NCT Number: NCT01047982

Myo-inositol in Obese Pregnant Women

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.

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Key information

Conditions

Gestational Diabetes Body Weight Cardiovascular Diseases Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hypertension Hypertension, Pregnancy-Induced Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Urogenital Diseases Vascular Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Obstetrics and Gynecology Unit, University of Messina and Obstetrics and Gynecology Unit of Modena University

Messina and Modena, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Myo-Inositol

Dietary Supplement

myo-inositol 2 grams plus folic acid 400 mcg twice a day

folic acid 400 mcg

Other

2 pills a day

Primary outcomes

  1. number of gestational diabetes cases diagnosed with OGTT

    Time frame: 24-28th weeks gestation

  2. difference in HOMA values

    Time frame: from first trimester to OGTT

Secondary outcomes

  1. incidence of pregnancy complications: hypertension, preterm delivery. macrosomia, shoulder dystocia, etc.

    Time frame: at delivery

Sponsors and collaborators

Lead sponsor

University of Messina

Other

Registry information

Official study title

Myo-inositol May Prevent Gestational Diabetes in Obese Women

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jan 13, 2010
Registry last updated
Feb 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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