Prevention of Gestational Diabetes (NuPreGDM)

March 25, 2022 updated by: University Hospital Tuebingen

Nutritional Prevention of Gestational Diabetes Mellitus

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Tübingen, Germany, 72076
        • Recruiting
        • University of Tuebingen, Department of Internal Medicine IV
        • Contact:
        • Principal Investigator:
          • Martin Heni, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycaemic excursion during an oral glucose tolerance test
Time Frame: gestational week (GW) 24 - 28
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose variability
Time Frame: Gestational week 14,20, 28, 34 and one week postpartum
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
Maternal weight gain during pregnancy
Time Frame: Gestational week 14,20, 28, 34
Body weight will be measured regularly during pregnancy.
Gestational week 14,20, 28, 34
Maternal insulin sensitivity
Time Frame: gestational week (GW) 24 - 28 and 6-12 weeks postpartum
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
Maternal insulin secretion
Time Frame: gestational week (GW) 24 - 28 and 6-12 weeks postpartum
Insulin secretion will be quantified from 5 point 75g oral glucose tolerance test.
gestational week (GW) 24 - 28 and 6-12 weeks postpartum
Fetal brain activity
Time Frame: Gestational week 28
Fetal brain activity will be assessed by fMEG (fetal magnetoencephalography).
Gestational week 28
Fetal heart rate variability
Time Frame: Gestational week 28
Fetal heart rate variability will be assessed by fMCG (fetal magnetocardiography).
Gestational week 28
Offsprings APGAR Score
Time Frame: Delivery
APGAR of the newborn will be recorded at time of birth
Delivery
Offsprings body weight
Time Frame: Delivery
Body weight of the newborn will be recorded at time of birth
Delivery
Offsprings body length
Time Frame: Delivery
Length of the newborn will be recorded at time of birth
Delivery
Offsprings head circumference
Time Frame: Delivery
Head circumference of the newborn will be recorded at time of birth
Delivery
Way of delivery
Time Frame: Delivery
Way of delivery (cesarean section or vaginal delivery) will be documented
Delivery
Time of delivery
Time Frame: Delivery
Time of delivery will be recorded as gestational week
Delivery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epigenetic modification
Time Frame: Delivery
Effect of maternal glycaemia on epigenetic marks in cord blood leucocytes of the newborn will be investigated by analysing DNA methylation.
Delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2019

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

November 1, 2023

Study Registration Dates

First Submitted

July 16, 2019

First Submitted That Met QC Criteria

July 19, 2019

First Posted (Actual)

July 22, 2019

Study Record Updates

Last Update Posted (Actual)

March 28, 2022

Last Update Submitted That Met QC Criteria

March 25, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due data protection regulation we will not be able to share patient level data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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