Improved Outcomes Associated With Inositol Dietary Supplementation in Women With Gestational Diabetes Mellitus (inositol)

G. d'Annunzio University

Status: Completed

Conditions: Gestational Diabetes Mellitus

Treatments: Dietary Supplement: Inositol

Study type: Observational

Funder types: Other

Identifiers

NCT01342874

INOS001

Details and patient eligibility

About

Objective: Insulin resistance during normal pregnancy and in gestational diabetes mellitus (GDM) are unknown. New criteria are based on fasting glucose levels since the beginning of pregnancy. Inositol, a putative second messenger of insulin, correlates with the degree of insulin resistance. Dietary supplementation of inositol improves insulin resistance in patients with GDM.

Full description

Methods: A randomized double-blind study was carried out in women with GDM. Patients were randomly exposed to inositol and placebo. Increase of BMI, blood glucose at 75 grams oral glucose tolerance test (OGTT), fetal and neonatal adverse outcome, and insulin treatment were correlated to inositol exposure.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• singleton pregnant women
• random fasting glucose above 92 mg%

Exclusion criteria

• BMI >30
• random fasting glucose above 126 mg%

Trial design

30 participants in 2 patient groups

Inositol group

Description:

Inositol dietary exposure 4000 mg/day

Treatment:

Dietary Supplement: Inositol

Control group

Description:

folic acid 400 mcg/day