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

Improved Maternal and Fetal Outcomes Associated With Inositol Dietary Supplementation in Women With Early Gestational Diabetes Mellitus

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01342874

Acronym

inositol

Enrollment

Registered

2011-04-27

Start date

2010-08-31

Completion date

2011-08-31

Last updated

2012-02-09

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

Conditions

Gestational Diabetes Mellitus

Keywords

inositol, gestational diabetes mellitus, obstetric adverse outcomes

Brief summary

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.

Detailed 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.

Interventions

DIETARY_SUPPLEMENTInositol

inositol exposure in early GDM

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* BMI \>30 * random fasting glucose above 126 mg%

Design outcomes

Primary

Measure	Time frame	Description
Insulin therapy in early diagnosis of GDM	6 months	Inositol supplementation and diet with/without insulin therapy in early GDM
altered OGTT	6 months	OGTT altered at 24-28 wks in inositol and control group

Secondary

Measure	Time frame	Description
delivery and neonatal outcomes	6 months	prevention of maternal and fetal adverse outcomes deriving from GDM (LGA fetuses, poly-hydramnios, C-section rate, gestational age at delivery, birthweight, birth injuries)

Countries

Italy

Outcome results

None listed

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