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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
University of Chieti
Information provided by (Responsible Party):
Claudio Celentano, G. d'Annunzio University
ClinicalTrials.gov Identifier:
NCT01762826
First received: November 25, 2012
Last updated: January 4, 2013
Last verified: September 2012
  Purpose

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


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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Adverse Obstetric Outcomes in Gestational Diabetes Mellitus and Inositol Stereoisomears

Resource links provided by NLM:


Further study details as provided by G. d'Annunzio University:

Primary Outcome Measures:
  • OGTT result [ Time Frame: 24-28 weeks' gestation ] [ Designated as safety issue: Yes ]
    OGTT is the mainstay of obstetric outcomes in GDM


Secondary Outcome Measures:
  • Fetal measurements at third trimester [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]
    Centiles of fetal measurements and amniotic fluid volume

  • Delivery data [ Time Frame: 25-42 weeks gestations' ] [ Designated as safety issue: Yes ]
    Gestational age at delivery Route of delivery Fetal gender Fetal weight (grams and centiles) Neonatal hypoglycemia

  • Adverse obstetric outcome [ Time Frame: from first elevated oral fasting glucose (above 92 mg%) till the end/termination of pregnancy (latter 42 weeks gestation) ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 120
Study Start Date: September 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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
Myo-inositol
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

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.

  Eligibility

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01762826

Sponsors and Collaborators
G. d'Annunzio University
University of Chieti
Investigators
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
  More Information

No publications provided

Responsible Party: Claudio Celentano, MD, G. d'Annunzio University
ClinicalTrials.gov Identifier: NCT01762826     History of Changes
Other Study ID Numbers: INOS002
Study First Received: November 25, 2012
Last Updated: January 4, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by G. d'Annunzio University:
Inositol
GDM

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

ClinicalTrials.gov processed this record on April 22, 2014