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

Adverse Obstetric Outcomes in Gestational Diabetes Mellitus and Inositol Stereoisomears

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01762826

Enrollment

120

Registered

2013-01-08

Start date

2012-09-30

Completion date

2013-09-30

Last updated

2013-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GDM

Keywords

Inositol, GDM

Brief summary

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

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.

Interventions

DIETARY_SUPPLEMENTMyo-inositol

Dietary control plus Myo-inositol

DIETARY_SUPPLEMENTD-chiro-inositol

Dietary control plus D-Chiro-Inositol supplementation

DIETARY_SUPPLEMENTD-Chiro / Myo-inositol

Dietary control Supplementation with myo and d-chiro inositol

DIETARY_SUPPLEMENTPlacebo

Dietary control plus folic acid 400 mcg daily

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Fetal measurements at third trimester	28 weeks	Centiles of fetal measurements and amniotic fluid volume
Delivery data	25-42 weeks gestations'	Gestational age at delivery Route of delivery Fetal gender Fetal weight (grams and centiles) Neonatal hypoglycemia
Adverse obstetric outcome	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026