Nutritional Prevention of Gestational Diabetes (NuPreGDM Study)

Gestational diabetes (GDM) is generally diagnosed only in the third trimester. However, increased maternal glucose levels may already have affected the fetus in an unfavorable manner by that time. Therefore, we aim to prevent excessive postprandial glucose excursions and their effects on fetal brain development through lifestyle modification starting in early pregnancy.  

  

In this randomized, controlled and open-label study, 50 women with an increased risk for gestational diabetes (pre-conceptional BMI ≥ 27 kg/m², GDM in previous pregnancy, positive family history for diabetes, previous macrosomia, or age ≥ 40 years) are randomized 1:1 into control or lifestyle intervention in the first trimester (gestational week 4 - 14). The intervention comprises regular individualized nutritional counseling and continuous glucose measurement using flash glucose monitoring. In both groups, a 5-point oral glucose tolerance test (OGTT) with 75 g glucose is conducted in the 28th week of pregnancy for metabolic phenotyping. Fetal magnetic encephalography and fetal magnetic cardiography is performed to assess fetal brain development. Umbilical cord blood is collected at delivery to analyze parameters of glucose metabolism as well as epigenetic markers. Another 5-point OGTT is performed in the mother 6 - 12 weeks after delivery. This randomized study investigates effects of glucose excursions in early pregnancy and in the further course of pregnancy on evolving maternal metabolism and child development. We further aim to assess whether the routine OGTT in the third trimester may be too late for some pregnant women, in particular for those at high risk for GDM development.

With the study we pursue two main objectives

  • Investigation of gestational diabetes as risk factor for the development of type 2 diabetes mellitus of the mother.
  • Impact of maternal metabolic disturbances during pregnancy on health and development of the offspring. In all study sites women are examined during pregnancy and repeatedly up to 10 years after delivery. Birth outcome as well as offspring anthropometric data are collected. Cord blood and placenta is collected and an offspring cohort is followed up at the Tübingen site.

Project Supervisor

Prof. Dr. Andreas Fritsche

Study registration

NCT04028089

Interested in participating?

Visit our Clinical Study Center