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

GDM Clinical Trial

Official title:

Adverse Obstetric Outcomes in Gestational Diabetes Mellitus and Inositol Stereoisomears

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01762826
• Other study ID #: INOS002
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 25, 2012
• Last updated: January 4, 2013
• Start date: September 2012
• Est. completion date: September 2013

Study information

• Verified date: September 2012
• Source: G. d'Annunzio University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: September 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes, Gestational
• GDM

Intervention

Dietary Supplement:
• Myo-inositol
Dietary control plus Myo-inositol
• D-chiro-inositol
Dietary control plus D-Chiro-Inositol supplementation
• D-Chiro / Myo-inositol
Dietary control Supplementation with myo and d-chiro inositol
• Placebo
Dietary control plus folic acid 400 mcg daily

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
G. d'Annunzio University	University of Chieti

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OGTT result	OGTT is the mainstay of obstetric outcomes in GDM	24-28 weeks' gestation	Yes
Secondary	Fetal measurements at third trimester	Centiles of fetal measurements and amniotic fluid volume	28 weeks	Yes
Secondary	Delivery data	Gestational age at delivery Route of delivery Fetal gender Fetal weight (grams and centiles) Neonatal hypoglycemia	25-42 weeks gestations'	Yes
Secondary	Adverse obstetric outcome	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)	Yes