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

G. d'Annunzio University

Status: Unknown

Conditions: GDM

Treatments: Dietary Supplement: Placebo; Dietary Supplement: D-chiro-inositol; Dietary Supplement: D-Chiro / Myo-inositol; Dietary Supplement: Myo-inositol

Study type: Observational

Funder types: Other

Identifiers

NCT01762826

INOS002

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

120 participants in 4 patient groups

Placebo control

Description:

Diet pills of 400 mcg of acid folic daily

Treatment:

Dietary Supplement: Placebo

D-chiro-inositol / Myo-inositol

Description:

Diet sachets 2000 mg myo-inositol and 250 mg d-chiro-inositol and 400 mcg folic acid daily

Treatment:

Dietary Supplement: D-Chiro / Myo-inositol

D-chiro-inositol

Description:

Diet pills with 500 mg d-chiro-inositol and 400 mcg folic acid daily

Treatment:

Dietary Supplement: D-chiro-inositol

Myo-inositol

Description:

Diet sachets with 2000 mg myo-inositol and 200 mcg folic acid twice daily

Treatment:

Dietary Supplement: Myo-inositol