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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05120388
Other study ID # 11012021
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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