Myo-inositol, D-chiro-inositol, and D-chiro/Myo-inositol in Gestational Diabetes

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. Identifier: NCT01762826
Recruitment Status : Unknown
Verified September 2012 by Claudio Celentano, G. d'Annunzio University.
Recruitment status was:  Enrolling by invitation
First Posted : January 8, 2013
Last Update Posted : January 8, 2013
University of Chieti
Information provided by (Responsible Party):
Claudio Celentano, G. d'Annunzio University

Brief Summary:
Comparison of different inositol stereoisomears in preventing adverse obstetric outcomes in non-obese pregnant women at high risk for gestational diabetes mellitus.

Condition or disease Intervention/treatment
GDM Dietary Supplement: Myo-inositol Dietary Supplement: D-chiro-inositol Dietary Supplement: D-Chiro / Myo-inositol Dietary Supplement: Placebo

Detailed Description:
The investigators compared outcomes from metabolic and obstetric point of view in GDM pregnant non-obese patient with different stereoisomears of inositol supply. Dietary control and placebo or inositol steroisomears were administered starting at the enrolling time (first fasting oral glucose above 92 mg%; usually before 20 weeks gestations') till the delivery and/or pregnancy end/termination. Oral glucose tolerance test results at 24-28 weeks' gestation was evaluated (as glucose values and oGTT screening). Fetal growth, delivery data, obstetric outcomes and necessity of insulin therapy were taken into account.

Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Adverse Obstetric Outcomes in Gestational Diabetes Mellitus and Inositol Stereoisomears
Study Start Date : September 2012
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Inositol
U.S. FDA Resources

Group/Cohort Intervention/treatment
Placebo control
Diet pills of 400 mcg of acid folic daily
Dietary Supplement: Placebo
Dietary control plus folic acid 400 mcg daily
D-chiro-inositol / Myo-inositol
Diet sachets 2000 mg myo-inositol and 250 mg d-chiro-inositol and 400 mcg folic acid daily
Dietary Supplement: D-Chiro / Myo-inositol
Dietary control Supplementation with myo and d-chiro inositol
Diet pills with 500 mg d-chiro-inositol and 400 mcg folic acid daily
Dietary Supplement: D-chiro-inositol
Dietary control plus D-Chiro-Inositol supplementation
Diet sachets with 2000 mg myo-inositol and 200 mcg folic acid twice daily
Dietary Supplement: Myo-inositol
Dietary control plus Myo-inositol
Other Name: Supplementation of myo-inositol plus dietary control

Primary Outcome Measures :
  1. OGTT result [ Time Frame: 24-28 weeks' gestation ]
    OGTT is the mainstay of obstetric outcomes in GDM

Secondary Outcome Measures :
  1. Fetal measurements at third trimester [ Time Frame: 28 weeks ]
    Centiles of fetal measurements and amniotic fluid volume

  2. Delivery data [ Time Frame: 25-42 weeks gestations' ]
    Gestational age at delivery Route of delivery Fetal gender Fetal weight (grams and centiles) Neonatal hypoglycemia

  3. Adverse obstetric outcome [ Time Frame: from first elevated oral fasting glucose (above 92 mg%) till the end/termination of pregnancy (latter 42 weeks gestation) ]
    Abortion Preterm delivery Polyhydramnios IUGR Macrosomia Fetal distress Preterm delivery pPROM Neonatal morbility (NICU stay, low glucose levels, etc.) Neonatal mortality Cerebral palsy Route of delivery Dystocia Etc.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Non obese pregnant women during first trimester of pregnancy with scared fasting glucose (above 92 mg%)

Inclusion Criteria:

  • pregnancy below 20 weeks gestation BMI below 30 Fasting glucose between 92 and 126 mg% Singleton pregnancy Naturally conceived

Exclusion Criteria:

  • obese patient Fasti g glucose above 126 or below 92

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 identifier (NCT number): NCT01762826

Sponsors and Collaborators
G. d'Annunzio University
University of Chieti
Study Director: Claudio Celentano, MD ObGyn Dept University of Chieti
Principal Investigator: Barbara Matarrelli, MD ObGyn Dept Univ of Chieti
Study Chair: Ester Vitacolonna, MD Diabetology Dept Univ of Chieti

Responsible Party: Claudio Celentano, MD, G. d'Annunzio University Identifier: NCT01762826     History of Changes
Other Study ID Numbers: INOS002
First Posted: January 8, 2013    Key Record Dates
Last Update Posted: January 8, 2013
Last Verified: September 2012

Keywords provided by Claudio Celentano, G. d'Annunzio University:

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