An interventional study of Diet Modification Group and Regular Diet Group in Gestational Diabetes, sponsored by University Hospital Tuebingen. Status unknown at 1 site in Germany. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-28.
Sponsored by University Hospital Tuebingen · Not applicable, Interventional, and Prevention
Pregnancy is a vulnerable period for both a mother and her developing child. The investigator hypothesizes that diet-induced glucose excursions in the pregnant mother are a key contributor to unfavourable brain development and epigenetic marks in the developing child. It is long known that metabolic conditions are influenced by maternal nutrition and that this can impact the unborn infant. The most prominent example is gestational diabetes (GDM). It is unclear at what point unfavourable changes in brain development occur during pregnancy. Unlike many previous trials, we plan to introduce healthy diet early in the first trimester. Comparative analyses of DNA methylation patterns in the offspring of women with or without GDM revealed preferentially methylated genes, particularly in pathways linked to metabolic diseases.
NuPreGDM is a randomized, controlled, open label intervention trail. The investigator aims to assess the effect of individual diet counselling combined with CGM compared to regular diet on glucose levels and postprandial glycemic excursions during an OGTT in pregnancy.
The investigator wants to assess the effect of dietary counselling combined with continuous glucose monitoring on GDM risk, glycaemia and pregnancy outcome, starting in the first trimester. The investigator further hypothesizes that improved glucose levels by a healthy diet will affect brain activity of the infant and prevent unfavourable epigenetic modifications.
The investigator plans to include 50 pregnant women within gestational week 4 and 14 after the last menstruation, with elevated risk for development of (GDM). Participants will be randomized 1:1 to either "diet modification group" (intervention) or to "standard diet group" (control). In the current trial, the investigator aims to modulate maternal metabolism with periodic personalized diet counselling on the basis of continuous glucose monitoring (CGM) compared to regular diet throughout pregnancy. The investigator propose that a reduction in glucose excursions in the mother will lead to a healthy environment for the developing child and prevent altered brain activity in utero, which will be assessed by fMEG (fetal magnetoencephalography) during a 75g OGTT in gestational week 28. The investigator further planned to examine child's leucocytes from cord blood to assess whether a healthy diet of the mother prevented epigenetic alterations due to improved maternal glycaemia, as exploratory endpoint. The development of blood sugar levels of the mother postpartum will be assessed by an further OGTT 6-12 weeks postpartum.
842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.
This study's planned enrollment of 50 is below the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →University Hospital Tuebingen is the lead sponsor of 476 studies on the registry; 104 are open to participants now.
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Exclusion Criteria:
Behavioral: Diet Modification Group
Other: Regular Diet Group
The diet modification group will receive diet counselling by an experienced dietician at least every four weeks throughout pregnancy starting in the first trimester. The dietary counselling will be guided by the individual glucose profiles obtained through flash glucose monitoring.
Participants of the "standard diet" will receive general diet counselling on one occasion at the onset of the study.
Glycaemic excursion during an oral glucose tolerance test
The effect of a diet modification on glucose levels and postprandial glycemic excursions (AUC) during a 75g oral glucose tolerance test (OGTT) will be measured.
Time frame: gestational week (GW) 24 - 28
Glucose variability
The effect of diet modification during pregnancy on 24h glucose profiles and postprandial glycemic excursions (AUC) will be measured by flash glucose monitoring.
Time frame: Gestational week 14,20, 28, 34 and one week postpartum
Maternal weight gain during pregnancy
Body weight will be measured regularly during pregnancy.
Time frame: Gestational week 14,20, 28, 34
Maternal insulin sensitivity
Whole body insulin sensitivity will be quantified from 5 point 75g oral glucose tolerance test.
Time frame: gestational week (GW) 24 - 28 and 6-12 weeks postpartum
Maternal insulin secretion
Insulin secretion will be quantified from 5 point 75g oral glucose tolerance test.
Time frame: gestational week (GW) 24 - 28 and 6-12 weeks postpartum
Fetal brain activity
Fetal brain activity will be assessed by fMEG (fetal magnetoencephalography).
Time frame: Gestational week 28
Fetal heart rate variability
Fetal heart rate variability will be assessed by fMCG (fetal magnetocardiography).
Time frame: Gestational week 28
Offsprings APGAR Score
APGAR of the newborn will be recorded at time of birth
Time frame: Delivery
Offsprings body weight
Body weight of the newborn will be recorded at time of birth
Time frame: Delivery
Offsprings body length
Length of the newborn will be recorded at time of birth
Time frame: Delivery
Offsprings head circumference
Head circumference of the newborn will be recorded at time of birth
Time frame: Delivery
Way of delivery
Way of delivery (cesarean section or vaginal delivery) will be documented
Time frame: Delivery
Time of delivery
Time of delivery will be recorded as gestational week
Time frame: Delivery
Epigenetic modification
Effect of maternal glycaemia on epigenetic marks in cord blood leucocytes of the newborn will be investigated by analysing DNA methylation.
Time frame: Delivery
Plan to share: No — Due data protection regulation we will not be able to share patient level data.
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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University Hospital Tuebingen