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

Completed

• Conditions: Gestational Diabetes Mellitus

• Registration Number: NCT01342874
• Lead Sponsor: G. d'Annunzio University

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.

Study Timeline

• Study Start: 2010-08
• Status Verified: 2011-04
• Primary Completion: 2011-04
• Study First Submitted: 2011-04-19
• Study First Submitted QC: 2011-04-26
• Study First Posted: 2011-04-27
• Study Completion: 2011-08
• Last Update Submitted: 2012-02-08
• Last Update Posted: 2012-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

University of Chieti; 🇮🇹 Chieti, CH, Italy