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NCT Number: NCT07817017

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

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.

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Key information

Conditions

Gestational Diabetes Mellitus (GDM) Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Mediterranean Diet Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Pregnancy Complications Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Nutritional intervention based on a Mediterranean diet

Other

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.

Primary outcomes

  1. Incidence of gestational diabetes mellitus

    Time frame: 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 outcomes

  1. Frequency of maternal complications

    Time frame: 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)

  2. Frequency of fetal complications

    Time frame: 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).

  3. Frequency of obstetric complications

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Ana M. Ramos-Levi, MD., PhD.

CONTACT

[email protected]

+33696938427

Sponsors and collaborators

Lead sponsor

Hospital San Carlos, Madrid

Other

Registry information

Official study title

Effect of an Early and Intensified Nutritional Intervention Based on a Mediterranean Diet (MedDiet) in Women With Clinical-genetic Risk of Developing Gestational Diabetes Mellitus (GDM): a Randomized, Parallel, Interventional, Controlled Clinical Trial

Acronym: MedDiet in GDM

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 14, 2026
Registry last updated
Sep 16, 2026

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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