Prevention of Gestational Diabetes

Gestational Diabetes Clinical Trial

— NuPreGDM  

Official title:

Nutritional Prevention of Gestational Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04028089
• Other study ID #: 104/2019BO1
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: November 1, 2023

Study information

• Verified date: March 2022
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Behavioral:
• Diet Modification 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.

Other:
• Regular Diet Group
Participants of the "standard diet" will receive general diet counselling on one occasion at the onset of the study.

Locations

Country	Name	City	State
Germany	University of Tuebingen, Department of Internal Medicine IV	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Epigenetic modification	Effect of maternal glycaemia on epigenetic marks in cord blood leucocytes of the newborn will be investigated by analysing DNA methylation.	Delivery
Primary	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.	gestational week (GW) 24 - 28
Secondary	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.	Gestational week 14,20, 28, 34 and one week postpartum
Secondary	Maternal weight gain during pregnancy	Body weight will be measured regularly during pregnancy.	Gestational week 14,20, 28, 34
Secondary	Maternal insulin sensitivity	Whole body insulin sensitivity will be quantified from 5 point 75g oral glucose tolerance test.	gestational week (GW) 24 - 28 and 6-12 weeks postpartum
Secondary	Maternal insulin secretion	Insulin secretion will be quantified from 5 point 75g oral glucose tolerance test.	gestational week (GW) 24 - 28 and 6-12 weeks postpartum
Secondary	Fetal brain activity	Fetal brain activity will be assessed by fMEG (fetal magnetoencephalography).	Gestational week 28
Secondary	Fetal heart rate variability	Fetal heart rate variability will be assessed by fMCG (fetal magnetocardiography).	Gestational week 28
Secondary	Offsprings APGAR Score	APGAR of the newborn will be recorded at time of birth	Delivery
Secondary	Offsprings body weight	Body weight of the newborn will be recorded at time of birth	Delivery
Secondary	Offsprings body length	Length of the newborn will be recorded at time of birth	Delivery
Secondary	Offsprings head circumference	Head circumference of the newborn will be recorded at time of birth	Delivery
Secondary	Way of delivery	Way of delivery (cesarean section or vaginal delivery) will be documented	Delivery
Secondary	Time of delivery	Time of delivery will be recorded as gestational week	Delivery