Gestational DiabetesNuPreGDMNCT04028089
Prevention of Gestational Diabetes
A study testing Diet Modification Group and Regular Diet Group in people with Gestational Diabetes, run by University Hospital Tuebingen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Diet Modification Group and Regular Diet Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jul 2019to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Tuebingen, Department of Internal Medicine IV
Tübingen, 72076
Martin Heni, MD, +49 7071 29 82714, martin.heni@med.uni-tuebingen.de
Andreas Fritsche, MD, +49 7071 29 82714, andreas.fritsche@med.uni-tuebingen.de
About this study
Official title: 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.
Read more
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.
- Conditions
- Gestational Diabetes
- Being tested
- Diet Modification Group, Regular Diet Group
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet Modification GroupBehavioural
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 GroupOther
Participants of the "standard diet" will receive general diet counselling on one occasion at the onset of the study.
| Study group | Role | What they receive |
|---|---|---|
| Diet Modification Group | Experimental | Not described Receives: Behavioral: Diet Modification Group |
| Regular Diet Group | Other | Not described Receives: Other: Regular Diet Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: gestational week (GW) 24 - 28
Secondary outcomes (12)
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.
Measured: Gestational week 14,20, 28, 34 and one week postpartum
Maternal weight gain during pregnancy
Body weight will be measured regularly during pregnancy.
Measured: Gestational week 14,20, 28, 34
Maternal insulin sensitivity
Whole body insulin sensitivity will be quantified from 5 point 75g oral glucose tolerance test.
Measured: gestational week (GW) 24 - 28 and 6-12 weeks postpartum
Maternal insulin secretion
Insulin secretion will be quantified from 5 point 75g oral glucose tolerance test.
Measured: gestational week (GW) 24 - 28 and 6-12 weeks postpartum
Fetal brain activity
Fetal brain activity will be assessed by fMEG (fetal magnetoencephalography).
Measured: Gestational week 28
Fetal heart rate variability
Fetal heart rate variability will be assessed by fMCG (fetal magnetocardiography).
Measured: Gestational week 28
Offsprings APGAR Score
APGAR of the newborn will be recorded at time of birth
Measured: Delivery
Offsprings body weight
Body weight of the newborn will be recorded at time of birth
Measured: Delivery
Offsprings body length
Length of the newborn will be recorded at time of birth
Measured: Delivery
Offsprings head circumference
Head circumference of the newborn will be recorded at time of birth
Measured: Delivery
Way of delivery
Way of delivery (cesarean section or vaginal delivery) will be documented
Measured: Delivery
Time of delivery
Time of delivery will be recorded as gestational week
Measured: Delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start15 Jul 2019
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028089
- Sponsor's protocol ID
- 104/2019BO1
- Acronym
- NuPreGDM
- Status last verified
- Mar 2022
- First submitted
- 16 Jul 2019
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due data protection regulation we will not be able to share patient level data.
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Prevention of Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04028089
- Acronym / sponsor ID
- NuPreGDM / 104/2019BO1
- Conditions
- Gestational Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 22 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet Modification Group | Experimental | Behavioral: Diet Modification Group |
| Regular Diet Group | Other | Other: Regular Diet Group |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet Modification GroupThe 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. | Behavioural | Diet Modification Group |
| Regular Diet GroupParticipants of the "standard diet" will receive general diet counselling on one occasion at the onset of the study. | Other | Regular Diet Group |
Primary outcome
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.
12 secondary outcomes
Glucose variability
Time frame: Gestational week 14,20, 28, 34 and one week postpartum
Maternal weight gain during pregnancy
Time frame: Gestational week 14,20, 28, 34
Maternal insulin sensitivity
Time frame: 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
Fetal brain activity
Time frame: Gestational week 28
Fetal heart rate variability
Time frame: Gestational week 28
Offsprings APGAR Score
Time frame: Delivery
Offsprings body weight
Time frame: Delivery
Offsprings body length
Time frame: Delivery
Offsprings head circumference
Time frame: Delivery
Way of delivery
Time frame: Delivery
Time of delivery
Time frame: Delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
- Individual participant dataSharing planned: No. Due data protection regulation we will not be able to share patient level data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
University of Tuebingen, Department of Internal Medicine IV
Tübingen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet Modification Group and Regular Diet Group in people with Gestational Diabetes, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycaemic excursion during an oral glucose tolerance test (time frame: gestational week (GW) 24 - 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2022.