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Prevention of Gestational Diabetes (NuPreGDM)

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ClinicalTrials.gov Identifier: NCT04028089
Recruitment Status : Recruiting
First Posted : July 22, 2019
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

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.


Condition or disease Intervention/treatment Phase
Gestational Diabetes Behavioral: Diet Modification Group Other: Regular Diet Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Nutritional Prevention of Gestational Diabetes Mellitus
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diet Modification Group 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.

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Maternal weight gain during pregnancy [ Time Frame: Gestational week 14,20, 28, 34 ]
    Body weight will be measured regularly during pregnancy.

  3. 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.

  4. 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.

  5. Fetal brain activity [ Time Frame: Gestational week 28 ]
    Fetal brain activity will be assessed by fMEG (fetal magnetoencephalography).

  6. Fetal heart rate variability [ Time Frame: Gestational week 28 ]
    Fetal heart rate variability will be assessed by fMCG (fetal magnetocardiography).

  7. Offsprings APGAR Score [ Time Frame: Delivery ]
    APGAR of the newborn will be recorded at time of birth

  8. Offsprings body weight [ Time Frame: Delivery ]
    Body weight of the newborn will be recorded at time of birth

  9. Offsprings body length [ Time Frame: Delivery ]
    Length of the newborn will be recorded at time of birth

  10. Offsprings head circumference [ Time Frame: Delivery ]
    Head circumference of the newborn will be recorded at time of birth

  11. Way of delivery [ Time Frame: Delivery ]
    Way of delivery (cesarean section or vaginal delivery) will be documented

  12. Time of delivery [ Time Frame: Delivery ]
    Time of delivery will be recorded as gestational week


Other Outcome Measures:
  1. Epigenetic modification [ Time Frame: Delivery ]
    Effect of maternal glycaemia on epigenetic marks in cord blood leucocytes of the newborn will be investigated.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04028089


Locations
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Germany
University of Tuebingen, Department of Internal Medicine IV Recruiting
Tübingen, Germany, 72076
Contact: Martin Heni, MD    +49 7071 29 82714    martin.heni@med.uni-tuebingen.de   
Contact: Andreas Fritsche, MD    +49 7071 29 82714    andreas.fritsche@med.uni-tuebingen.de   
Principal Investigator: Martin Heni, MD         
Sponsors and Collaborators
University Hospital Tuebingen

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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT04028089     History of Changes
Other Study ID Numbers: 104/2019BO1
First Posted: July 22, 2019    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Due data protection regulation we will not be able to share patient level data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications