Clinical trial NCT04028089: Prevention of Gestational Diabetes
Official title: Nutritional Prevention of Gestational Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2019-07-22
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Pregnant women between gestational week 4 and 14 after the last menstruation (proof of b-human choriongonadotropin in urine or proof of pregnancy via ultrasound.)
* Pre-pregnancy overweight (pregravid BMI \> = 27) or positive family history of type 2 diabetes or GDM in first-degree relatives or GDM in previous pregnancy or previous macrosomia (baby with birth weight \> 4000 g) or advanced maternal age \> = 40 years
* Ability to understand and voluntarily sign an informed consent document prior to any study related procedures.

Exclusion Criteria:

* Age \< 18 years
* Multiple pregnancy
* Pre-pregnancy Diabetes mellitus
* Intake of medication that interferes with glucose-metabolism, such as glucose lowering or increasing drugs at inclusion visit (e.g. Steroids, Antidiabetics, Insulin, Metformin)
* Treatment with drugs with central nervous actions
* Chronic alcohol disease and drug abuse
* Pre-existing cardiac condition
* Mental disorder
* Weight loss \>10% in the previous 6 months
* GFR \< 60 ml/min/1.73 m2
* 2-fold increased transaminase levels in reference to the upper standard
* Any other (clinical) condition that would endanger participant's safety or question scientific success according to a physician's opinion.

Primary outcomes:
measure: Glycaemic excursion during an oral glucose tolerance test
timeFrame: gestational week (GW) 24 - 28
Secondary outcomes:
measure: Glucose variability
timeFrame: Gestational week 14,20, 28, 34 and one week postpartum
measure: Maternal weight gain during pregnancy
timeFrame: Gestational week 14,20, 28, 34
measure: Maternal insulin sensitivity
timeFrame: gestational week (GW) 24 - 28 and 6-12 weeks postpartum
measure: Maternal insulin secretion
timeFrame: gestational week (GW) 24 - 28 and 6-12 weeks postpartum
measure: Fetal brain activity
timeFrame: Gestational week 28
measure: Fetal heart rate variability
timeFrame: Gestational week 28
measure: Offsprings APGAR Score
timeFrame: Delivery
measure: Offsprings body weight
timeFrame: Delivery
measure: Offsprings body length
timeFrame: Delivery
measure: Offsprings head circumference
timeFrame: Delivery
measure: Way of delivery
timeFrame: Delivery
measure: Time of delivery
timeFrame: Delivery
Other outcomes:
measure: Epigenetic modification
timeFrame: Delivery
Locations:
city: Tübingen
country: Germany
facility: University of Tuebingen, Department of Internal Medicine IV
Study officials:
References: