Gestational Diabetes
Conditions
Keywords
gestational diabetes, macrosomia, hypertension in pregnancy, HOMA-IR, obesity
Brief summary
Myo-Inositol is classified as a member of the vitamin B complex. It is a constituent of living cells and is widespread in many food. It is involved in a number of biological processes, including insulin signal transduction, resulting in modulating insulin sensitivity. This is a prospective, randomized, double center, placebo-controlled study. Two hundred and twenty obese pregnant women will be included in the trial and, after an informed consent, will assume randomly 2 g of myo-inositol twice a day or placebo from 12-13th weeks gestation until delivery. Then,they will perform an Oral Glucose Tolerance Test (OGTT) at 24-28th weeks gestation. Records about delivery (gestational age, neonatal weight...) will be registered.
Interventions
DIETARY_SUPPLEMENTmyo-inositol
myo-inositol 2 grams plus folic acid 400 mcg twice a day
OTHERfolic acid 400 mcg
2 pills a day
Sponsors
University of Messina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Obese pregnant women: BMI \> 30 Kg/cm2 * first trimester fast glycaemia \< 126 mg/dl * single pregnancy
Exclusion criteria
* Pregnant women with BMI \< 30 Kg/cm2 * first trimester fast glycaemia \> 126 mg/dl * previous gestational diabetes * twin pregnancy * pregestational diabetes * associated therapies with corticosteroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of gestational diabetes cases diagnosed with OGTT | 24-28th weeks gestation |
| difference in HOMA values | from first trimester to OGTT |
Secondary
| Measure | Time frame |
|---|---|
| incidence of pregnancy complications: hypertension, preterm delivery. macrosomia, shoulder dystocia, etc. | at delivery |
Countries
Italy
Outcome results
None listed