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Effect of an Early and Intensified Nutritional Intervention on the Risk of Developing Gestational Diabetes Mellitus

Study acronym: MedDiet in GDM
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Study title revised
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to learn if a nutritional intervention based on a Mediterranean diet (MedDiet), initiated early in pregnancy, reduces the incidence of gestational diabetes mellitus (GDM) and other adverse maternal, fetal and obstetric events in pregnant women considered high-risk. It will also learn about the stratification of GDM risk based on clinical, anthropometric, analytical and genetic characteristics. The main questions it aims to answer are: * Does the nutritional intervention based on MedDiet reduce the incidence of GDM in women with high risk? * How can we stratify the risk of GDM? Researchers will compare an advanced nutritional intervention based on a Mediterranean diet to standard care (general recommendations given at the beginning of pregnancy). Participants will: * Receive intensive nutritional counselling or standard regular recommendations during the first trimester of pregnancy. * Visit the clinic at the time of the first ultrasound (gestational week 8-11) and at the time of screening for GDM (gestational week 24-26). * Undergo a genetic test performed with a buccal swab.
Trial Details
NCT Number NCT07817017
Lead Sponsor Hospital San Carlos, Madrid
Conditions
(from sponsor)
Gestational Diabetes Mellitus (GDM), Pregnancy, Mediterranean Diet
Related terms Diabetes, Gestational
Enrollment 1,200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov