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
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: 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 August 20, 2014