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

January 4, 2013 updated by: Claudio Celentano, G. d'Annunzio University

Adverse Obstetric Outcomes in Gestational Diabetes Mellitus and Inositol Stereoisomears

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Actual)

120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Non obese pregnant women during first trimester of pregnancy with scared fasting glucose (above 92 mg%)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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
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 Names:
  • Supplementation of myo-inositol plus dietary control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OGTT result
Time Frame: 24-28 weeks' gestation
OGTT is the mainstay of obstetric outcomes in GDM
24-28 weeks' gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fetal measurements at third trimester
Time Frame: 28 weeks
Centiles of fetal measurements and amniotic fluid volume
28 weeks
Delivery data
Time Frame: 25-42 weeks gestations'
Gestational age at delivery Route of delivery Fetal gender Fetal weight (grams and centiles) Neonatal hypoglycemia
25-42 weeks gestations'
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.
from first elevated oral fasting glucose (above 92 mg%) till the end/termination of pregnancy (latter 42 weeks gestation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

G. d'Annunzio University

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

April 1, 2013

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

November 25, 2012

First Submitted That Met QC Criteria

January 4, 2013

First Posted (Estimate)

January 8, 2013

Study Record Updates

Last Update Posted (Estimate)

January 8, 2013

Last Update Submitted That Met QC Criteria

January 4, 2013

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INOS002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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