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

NCT05120388 | Completed

• 1 other identifier: 11012021
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes

Keywords

GDM; Extra Virgin Olive Oil; lipid profile; insulin requirement; postpartum reclassification

Outcome Measures

Primary Outcomes (3)

• maternal triglyceridemia

  triglycerides in mg/dl

  term pregnancy

• maternal weight gain

  gestational maternal weight gain in kg

  change from prepregnancy weight to term pregnancy weight

• number of participants with insulin requirement

  insulin use

  term pregnancy

Secondary Outcomes (1)

• number of participants with diabetes at postpartum

  six weeks postpartum

Study Arms (2)

Dietary addition of extra virgin olive oil

EXPERIMENTAL

WHO diet with a daily addition of extra virgin olive oil

Dietary Supplement: Extra Virgin Olive Oil Addition

No addition of extra virgin Olive Oil

NO INTERVENTION

WHO diet

Interventions

Extra Virgin Olive Oil Addition DIETARY_SUPPLEMENT

Daily dietary addition of olive oil (three tablespoons)

Dietary addition of extra virgin olive oil

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Multiple pregnancy
• Pregestational diabetes (type 1 or type 2)
• Bariatric surgery
• Infectious diseases

Sponsors & Collaborators

• Center for Pharmacological and Botanical Research: lead
• Sociedad Argentina de Diabetes: collaborator

Study Sites (1)

Unidad Patagonica de Medicina Maternofetal y Embarazo de Alto Riesgo

Neuquén, Neuquén Province, Q8300BCI, Argentina

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Data analysis will be masked
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Dietary intervention study: GDM patients receiving a WHO diet with or without addition of extra virgin olive oil

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: November 15, 2021
• Study Start: January 11, 2022
• Primary Completion: April 15, 2024
• Study Completion: August 19, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

AR (1)