Effect of Extra Virgin Olive Oil Addition in the Diet of Women With Gestational Diabetes Mellitus (OLIDIAG) (OLIDIAG)
Primary Purpose
Gestational Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Extra Virgin Olive Oil Addition
Sponsored by
About this trial
This is an interventional prevention trial for Gestational Diabetes focused on measuring GDM, Extra Virgin Olive Oil, lipid profile, insulin requirement, postpartum reclassification
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
Sites / Locations
- Unidad Patagonica de Medicina Maternofetal y Embarazo de Alto RiesgoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Dietary addition of extra virgin olive oil
No addition of extra virgin Olive Oil
Arm Description
WHO diet with a daily addition of extra virgin olive oil
WHO diet
Outcomes
Primary Outcome Measures
maternal triglyceridemia
triglycerides in mg/dl
maternal weight gain
gestational maternal weight gain in kg
number of participants with insulin requirement
insulin use
Secondary Outcome Measures
number of participants with diabetes at postpartum
maternal diagnosis of diabetes at postpartum
Full Information
NCT ID
NCT05120388
First Posted
October 14, 2021
Last Updated
September 15, 2023
Sponsor
Center for Pharmacological and Botanical Research
Collaborators
Sociedad Argentina de Diabetes
1. Study Identification
Unique Protocol Identification Number
NCT05120388
Brief Title
Effect of Extra Virgin Olive Oil Addition in the Diet of Women With Gestational Diabetes Mellitus (OLIDIAG)
Acronym
OLIDIAG
Official Title
Effect of Extra Virgin Olive Oil Addition in the Diet of Women With Gestational Diabetes Mellitus (OLIDIAG)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2022 (Actual)
Primary Completion Date
April 15, 2024 (Anticipated)
Study Completion Date
December 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center for Pharmacological and Botanical Research
Collaborators
Sociedad Argentina de Diabetes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
Keywords
GDM, Extra Virgin Olive Oil, lipid profile, insulin requirement, postpartum reclassification
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Dietary intervention study: GDM patients receiving a WHO diet with or without addition of extra virgin olive oil
Masking
Investigator
Masking Description
Data analysis will be masked
Allocation
Randomized
Enrollment
1200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dietary addition of extra virgin olive oil
Arm Type
Experimental
Arm Description
WHO diet with a daily addition of extra virgin olive oil
Arm Title
No addition of extra virgin Olive Oil
Arm Type
No Intervention
Arm Description
WHO diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Extra Virgin Olive Oil Addition
Intervention Description
Daily dietary addition of olive oil (three tablespoons)
Primary Outcome Measure Information:
Title
maternal triglyceridemia
Description
triglycerides in mg/dl
Time Frame
term pregnancy
Title
maternal weight gain
Description
gestational maternal weight gain in kg
Time Frame
change from prepregnancy weight to term pregnancy weight
Title
number of participants with insulin requirement
Description
insulin use
Time Frame
term pregnancy
Secondary Outcome Measure Information:
Title
number of participants with diabetes at postpartum
Description
maternal diagnosis of diabetes at postpartum
Time Frame
six weeks postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alicia Jawerbaum, PhD
Phone
+541152853605
Email
a.jawerbaum@gmail.com
Facility Information:
Facility Name
Unidad Patagonica de Medicina Maternofetal y Embarazo de Alto Riesgo
City
Neuquén
State/Province
Neuquen
ZIP/Postal Code
Q8300BCI
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alicia Jawerbaum, PhD
Phone
+541152853605
Email
a.jawerbaum@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Effect of Extra Virgin Olive Oil Addition in the Diet of Women With Gestational Diabetes Mellitus (OLIDIAG)
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