Effect of Extra Virgin Olive Oil Addition in the Diet of Women With Gestational Diabetes Mellitus (OLIDIAG)

Study Overview
=================
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.

Official Title
-----------------
Effect of Extra Virgin Olive Oil Addition in the Diet of Women With Gestational Diabetes Mellitus (OLIDIAG)

Conditions
-----------------
Gestational Diabetes

Intervention / Treatment
-----------------
* Dietary Supplement: Extra Virgin Olive Oil Addition


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Dietary intervention study: GDM patients receiving a WHO diet with or without addition of extra virgin olive oil
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary addition of extra virgin olive oil<br>WHO diet with a daily addition of extra virgin olive oil | Dietary Supplement: Extra Virgin Olive Oil Addition<br>* Daily dietary addition of olive oil (three tablespoons)<br>|
| No Intervention: No addition of extra virgin Olive Oil<br>WHO diet | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maternal triglyceridemia | triglycerides in mg/dl | term pregnancy | 
| maternal weight gain | gestational maternal weight gain in kg | change from prepregnancy weight to term pregnancy weight | 
| number of participants with insulin requirement | insulin use | term pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with diabetes at postpartum | maternal diagnosis of diabetes at postpartum | six weeks postpartum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GDM, Extra Virgin Olive Oil, lipid profile, insulin requirement, postpartum reclassification