Improved Maternal and Fetal Outcomes Associated With Inositol Dietary Supplementation in Women With Early Gestational Diabetes Mellitus
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gestational Diabetes Mellitus
- Sponsor
- G. d'Annunzio University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Insulin therapy in early diagnosis of GDM
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Claudio Celentano
MD
G. d'Annunzio University
Eligibility Criteria
Inclusion Criteria
- •singleton pregnant women
- •random fasting glucose above 92 mg%
Exclusion Criteria
- •random fasting glucose above 126 mg%
Outcomes
Primary Outcomes
Insulin therapy in early diagnosis of GDM
Time Frame: 6 months
Inositol supplementation and diet with/without insulin therapy in early GDM
altered OGTT
Time Frame: 6 months
OGTT altered at 24-28 wks in inositol and control group
Secondary Outcomes
- delivery and neonatal outcomes(6 months)