Gestational diabetes mellitus (GDM) is associated to adverse maternal and neonatal outcomes. The aim of this study is to address whether the addition of extra virgin olive oil to the diet of women with GDM improves maternal triglyceridemia and reduces insulin requirement and diagnosis of diabetes at postnatal reclassification.
This study is a randomized trial in which 1200 pregnant women at GDM diagnosis from 16 health care centers will be recruited and randomized in two parallel arms: 1 World Health Organization (WHO)-diet supplemented with 3 tablespoons of Extra Virgin Olive Oil (Intervention Group, n=600); 2. WHO-diet with no Extra Virgin Olive Oil supplementation (Control Group, n=600). Expected results: the investigators expect that the intervention will contribute to improve maternal lipid profile, reduce insulin requirement and reduce maternal diagnosis of diabetes at postpartum reclassification. Thus, this study is expected to identify maternal beneficial effects of this dietary intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
190
Daily dietary addition of olive oil (three tablespoons)
Unidad Patagonica de Medicina Maternofetal y Embarazo de Alto Riesgo
Neuquén, Neuquén Province, Argentina
maternal triglyceridemia
triglycerides in mg/dl
Time frame: term pregnancy
maternal weight gain
gestational maternal weight gain in kg
Time frame: change from prepregnancy weight to term pregnancy weight
number of participants with insulin requirement
insulin use
Time frame: term pregnancy
number of participants with diabetes at postpartum
maternal diagnosis of diabetes at postpartum
Time frame: six weeks postpartum
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