Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05120388
Study type Interventional
Source Center for Pharmacological and Botanical Research
Contact Alicia Jawerbaum, PhD
Phone +541152853605
Email a.jawerbaum@gmail.com
Status Recruiting
Phase N/A
Start date January 11, 2022
Completion date December 15, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05081037 - Integrated Hyperglycaemia Incentivised Postnatal Surveillance Study (I-HIPS) N/A
Active, not recruiting NCT03249896 - Web/Smartphone-based Lifestyle Coaching Program in Pregnant Women With Gestational Diabetes N/A
Terminated NCT03749889 - Low Carb vs Normal Carb in Pregnancy N/A
Completed NCT03859193 - Education Nutritional Video for Gestational Diabetics N/A
Recruiting NCT05037526 - Utility of Real Time Continuous Glucose Monitoring in the Care of Gestational Diabetes Versus Standard Care in Pregnancy Outcomes N/A
Completed NCT06178250 - Placenta, Fetal Liver, Sectional Ductus Venosus Volumes Examined by Three-dimensional Ultrasound in the Second Trimester N/A
Not yet recruiting NCT06310356 - Continuous Glucose Monitoring for Women With Gestational Diabetes N/A
Not yet recruiting NCT06445530 - Nutrition Optimization and Community Upliftment for Postpartum Recovery N/A
Recruiting NCT02590016 - Glucose Control During Labour in Gestational Diabetes Mellitus With Insulin Treatment: A Randomized Controlled Trial Phase 4
Not yet recruiting NCT00883259 - Metformin and Gestational Diabetes in High-risk Patients: a RCTs Phase 4
Withdrawn NCT01947699 - Glycemic Profile in Women With Gestational Diabetes Treated With Glyburide Phase 4
Recruiting NCT03008824 - Micronutrients in Pregnancy as a Risk Factor for Diabetes and Effects on Mother and Baby N/A
Active, not recruiting NCT01340924 - Relationship Between Gestational Diabetes and Type 2 Diabetes
Completed NCT00534105 - Lipid Metabolism in Gestational Diabetes N/A
Recruiting NCT00371306 - Comparison of Glucovance to Insulin for Diabetes During Pregnancy N/A
Completed NCT03388723 - Intergenerational Programming of Diabesity in Offspring of Women With Gestational Diabetes Mellitus
Recruiting NCT04521712 - Postpartum Glycemia in Women at Risk For Persistent Hyperglycemia N/A
Enrolling by invitation NCT03307486 - Gestational Diabetes: a Cohort Study N/A
Active, not recruiting NCT03301792 - Group Versus Traditional Prenatal Care for Diabetes N/A
Enrolling by invitation NCT05603793 - YoUng Adolescents' behaViour, musculoskeletAl heAlth, Growth & Nutrition