Prevention of Gestational Diabetes (NuPreGDM)
Primary Purpose
Gestational Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Diet Modification Group
Regular Diet Group
Sponsored by
About this trial
This is an interventional prevention trial for Gestational Diabetes
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.
Sites / Locations
- University of Tuebingen, Department of Internal Medicine IVRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Diet Modification Group
Regular Diet Group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Maternal weight gain during pregnancy
Body weight will be measured regularly during pregnancy.
Maternal insulin sensitivity
Whole body insulin sensitivity will be quantified from 5 point 75g oral glucose tolerance test.
Maternal insulin secretion
Insulin secretion will be quantified from 5 point 75g oral glucose tolerance test.
Fetal brain activity
Fetal brain activity will be assessed by fMEG (fetal magnetoencephalography).
Fetal heart rate variability
Fetal heart rate variability will be assessed by fMCG (fetal magnetocardiography).
Offsprings APGAR Score
APGAR of the newborn will be recorded at time of birth
Offsprings body weight
Body weight of the newborn will be recorded at time of birth
Offsprings body length
Length of the newborn will be recorded at time of birth
Offsprings head circumference
Head circumference of the newborn will be recorded at time of birth
Way of delivery
Way of delivery (cesarean section or vaginal delivery) will be documented
Time of delivery
Time of delivery will be recorded as gestational week
Full Information
NCT ID
NCT04028089
First Posted
July 16, 2019
Last Updated
March 25, 2022
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT04028089
Brief Title
Prevention of Gestational Diabetes
Acronym
NuPreGDM
Official Title
Nutritional Prevention of Gestational Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diet Modification Group
Arm Type
Experimental
Arm Title
Regular Diet Group
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Diet Modification Group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Regular Diet Group
Intervention Description
Participants of the "standard diet" will receive general diet counselling on one occasion at the onset of the study.
Primary Outcome Measure Information:
Title
Glycaemic excursion during an oral glucose tolerance test
Description
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
Secondary Outcome Measure Information:
Title
Glucose variability
Description
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
Title
Maternal weight gain during pregnancy
Description
Body weight will be measured regularly during pregnancy.
Time Frame
Gestational week 14,20, 28, 34
Title
Maternal insulin sensitivity
Description
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
Title
Maternal insulin secretion
Description
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
Title
Fetal brain activity
Description
Fetal brain activity will be assessed by fMEG (fetal magnetoencephalography).
Time Frame
Gestational week 28
Title
Fetal heart rate variability
Description
Fetal heart rate variability will be assessed by fMCG (fetal magnetocardiography).
Time Frame
Gestational week 28
Title
Offsprings APGAR Score
Description
APGAR of the newborn will be recorded at time of birth
Time Frame
Delivery
Title
Offsprings body weight
Description
Body weight of the newborn will be recorded at time of birth
Time Frame
Delivery
Title
Offsprings body length
Description
Length of the newborn will be recorded at time of birth
Time Frame
Delivery
Title
Offsprings head circumference
Description
Head circumference of the newborn will be recorded at time of birth
Time Frame
Delivery
Title
Way of delivery
Description
Way of delivery (cesarean section or vaginal delivery) will be documented
Time Frame
Delivery
Title
Time of delivery
Description
Time of delivery will be recorded as gestational week
Time Frame
Delivery
Other Pre-specified Outcome Measures:
Title
Epigenetic modification
Description
Effect of maternal glycaemia on epigenetic marks in cord blood leucocytes of the newborn will be investigated by analysing DNA methylation.
Time Frame
Delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
University of Tuebingen, Department of Internal Medicine IV
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Heni, MD
Phone
+49 7071 29 82714
Email
martin.heni@med.uni-tuebingen.de
First Name & Middle Initial & Last Name & Degree
Andreas Fritsche, MD
Phone
+49 7071 29 82714
Email
andreas.fritsche@med.uni-tuebingen.de
First Name & Middle Initial & Last Name & Degree
Martin Heni, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Due data protection regulation we will not be able to share patient level data.
Learn more about this trial
Prevention of Gestational Diabetes
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