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NCT07817017
Effect of an Early and Intensified Nutritional Intervention on the Risk of Developing Gestational Diabetes Mellitus
Conditions: Gestational Diabetes Mellitus (GDM), Pregnancy, Mediterranean Diet
Sex: Female
Ages: 18 Years – 50 Years
Healthy volunteers: No
Phase: NA
Enrollment: 1200
Sponsor: Hospital San Carlos, Madrid
Location: Hospital Clínico San Carlos Madrid Madrid
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Unassisted single pregnancy;
* Age between 18 and 50 years old;
* Fasting blood glucose \
Source: ClinicalTrials.gov (NCT07817017). StuddyBuddy aggregates publicly available trial information.