Gestational Diabetes
Conditions
Keywords
GDM, Extra Virgin Olive Oil, lipid profile, insulin requirement, postpartum reclassification
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTExtra Virgin Olive Oil Addition
Daily dietary addition of olive oil (three tablespoons)
Sponsors
Sociedad Argentina de Diabetes
Center for Pharmacological and Botanical Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Masking description
Data analysis will be masked
Intervention model description
Dietary intervention study: GDM patients receiving a WHO diet with or without addition of extra virgin olive oil
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* GDM (diagnosis criteria of the Latin American Society of Diabetes (ALAD) and Argentine Society of Diabetes (SAD): Fasting plasma glucosa \> 100 mg/dl, p75 oral glucose tolerance test-2 h plasma glucose \> 140 mg/dl)
Exclusion criteria
* Multiple pregnancy * Pregestational diabetes (type 1 or type 2) * Bariatric surgery * Infectious diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| maternal triglyceridemia | term pregnancy | triglycerides in mg/dl |
| maternal weight gain | change from prepregnancy weight to term pregnancy weight | gestational maternal weight gain in kg |
| number of participants with insulin requirement | term pregnancy | insulin use |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of participants with diabetes at postpartum | six weeks postpartum | maternal diagnosis of diabetes at postpartum |
Countries
Argentina
Outcome results
None listed