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

Gestational Diabetes Clinical Trial

— OLIDIAG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05120388
• Other study ID #: 11012021
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2022
• Est. completion date: December 15, 2024

Study information

• Verified date: September 2023
• Source: Center for Pharmacological and Botanical Research
• Contact: Alicia Jawerbaum, PhD
• Phone: +541152853605
• Email: a.jawerbaum[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 15, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Dietary Supplement:
• Extra Virgin Olive Oil Addition
Daily dietary addition of olive oil (three tablespoons)

Locations

Country	Name	City	State
Argentina	Unidad Patagonica de Medicina Maternofetal y Embarazo de Alto Riesgo	Neuquén	Neuquen

Sponsors (2)

Lead Sponsor	Collaborator
Center for Pharmacological and Botanical Research	Sociedad Argentina de Diabetes

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maternal triglyceridemia	triglycerides in mg/dl	term pregnancy
Primary	maternal weight gain	gestational maternal weight gain in kg	change from prepregnancy weight to term pregnancy weight
Primary	number of participants with insulin requirement	insulin use	term pregnancy
Secondary	number of participants with diabetes at postpartum	maternal diagnosis of diabetes at postpartum	six weeks postpartum