Improved Outcomes Associated With Inositol Dietary Supplementation in Women With Gestational Diabetes Mellitus (inositol)
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Improved Maternal and Fetal Outcomes Associated With Inositol Dietary Supplementation in Women With Early Gestational Diabetes Mellitus|
- Insulin therapy in early diagnosis of GDM [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Inositol supplementation and diet with/without insulin therapy in early GDM
- altered OGTT [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]OGTT altered at 24-28 wks in inositol and control group
- delivery and neonatal outcomes [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]prevention of maternal and fetal adverse outcomes deriving from GDM (LGA fetuses, poly-hydramnios, C-section rate, gestational age at delivery, birthweight, birth injuries)
|Study Start Date:||August 2010|
|Study Completion Date:||August 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Inositol dietary exposure 4000 mg/day
Dietary Supplement: Inositol
inositol exposure in early GDM
folic acid 400 mcg/day
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.