Gestational Diabetes Mellitus (GDM), Mediterranean Diet, Pregnancy
Conditions
Keywords
gestational diabetes mellitus, pregnancy, mediterranean diet, poligenic risk score, genetic polymorphism
Brief 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.
Interventions
OTHERNutritional intervention based on a Mediterranean diet
The nutritional intervention consists of a 1-hour group session led by a nutritionist from the research team. Includes a detailed description of the key aspects of the MedDiet: consumption of \>40 ml/day of extra virgin olive oil, 30 g of nuts per day, 3-4 pieces of whole fruit (not juice), homemade stir-fries, 2-3 servings of vegetables and/or salads per day, 2-3 servings per day of low-fat dairy products, whole grains, 2-3 servings of legumes per week, consumption of fish, limiting the consumption of red meat, and avoiding ultra-processed products, sliced bread, soft drinks, juices, fast food, and pre-cooked products. In addition, 2 telephonic interviews for follow-up (gestational weeks 16 and 20) to reinforce adherence and emphasize consumption of \>40 ml/day of extra virgin olive oil, 30 g of nuts per day, 3-4 pieces of whole fruit (not juice), daily vegetables and daily physical activity.
Sponsors
Hospital San Carlos, Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Unassisted single pregnancy; * Age between 18 and 50 years old; * Fasting blood glucose \<92 mg/dl in the first gestational blood test; * First trimester ultrasound before the 12th gestational week.
Exclusion criteria
* Multiple or assisted pregnancies; * Any pregestational illness or pregestational treatment that may affect pregnancy; * Known intolerance/allergy to any component of the nutritional intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of gestational diabetes mellitus | From enrollment (gestational week 8-11) to the time of screening for gestational diabetes mellitus (gestational week 24-26) | The general objective of this study is to determine whether an advanced nutritional intervention based on Mediterranean diet reduces the incidence of gestational diabetes mellitus and other adverse maternal-fetal obstetric and endocrine-metabolic events in pregnant women considered high-risk based on a risk score derived from the interaction between associated genetic polymorphisms, baseline clinical characteristics, and anthropometric characteristics of pregnant women. The primary outcome is the comparison of the frequency of GDM, according to IADPSG criteria, between the MedDiet intervention group and the standard treatment group in women at high risk according to the calculated risk of developing GDM. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of maternal complications | From enrollment (gestational week 8-11) to delivery | Frequency of maternal complications between the MedDiet intervention group and the standard treatment group in women at high risk according to the calculated risk of developing GDM. Variables for this outcome include: maternal weight, weight gain; risk score; frequency of maternal complications (hypertension, eclampsia, infections, carbohydrate metabolism disorders - defined as alterations in normal levels of at least one of the following: fasting glucose, HbA1c, C-peptide, insulin, HOMA-IR) |
| Frequency of fetal complications | From enrollment (gestational week 8-11) to delivery and neonatal period | Comparison of the frequency of fetal complications between the MedDiet intervention group and the standard treatment group in high-risk women, based on the calculated risk of developing gestational diabetes mellitus (GDM). Variables for this outcome include: birth weight, hypoglycemia, potassium abnormalities, calcium abnormalities, polycythemia, admission to the neonatal intensive care unit (NICU). |
| Frequency of obstetric complications | From enrollment (gestational week 8-11) to delivery and immediate postpartum | Comparison of the frequency of obstetric complications between the MedDiet intervention group and the standard treatment group in women at high risk of developing GDM. Variables for this outcome include: type of delivery, dystocia, lacerations during delivery, preterm or postterm delivery (gestational week at delivery). |
Countries
Spain
Contacts
CONTACTAna M. Ramos-Levi, MD., PhD.
Outcome results
None listed