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Completed

NCT Number: NCT05120388

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

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.

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Unidad Patagonica de Medicina Maternofetal y Embarazo de Alto Riesgo

Neuquén, Neuquén Province, Q8300BCI, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extra Virgin Olive Oil Addition

Dietary Supplement

Daily dietary addition of olive oil (three tablespoons)

Primary outcomes

  1. maternal triglyceridemia

    Time frame: term pregnancy

    triglycerides in mg/dl

  2. maternal weight gain

    Time frame: change from prepregnancy weight to term pregnancy weight

    gestational maternal weight gain in kg

  3. number of participants with insulin requirement

    Time frame: term pregnancy

    insulin use

Secondary outcomes

  1. number of participants with diabetes at postpartum

    Time frame: six weeks postpartum

    maternal diagnosis of diabetes at postpartum

Sponsors and collaborators

Lead sponsor

Center for Pharmacological and Botanical Research

Other Gov

Collaborators

  • Sociedad Argentina de Diabetes

Registry information

Acronym: OLIDIAG

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 15, 2021
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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