Gestational Diabetes Mellitus in ChildbirthGD-BRAINNCT03032991
Early Biomarkers of Neurodevelopment in Offspring of Diabetic Mothers
An observational study of Gestational Diabetes Mellitus in Childbirth and Neurodevelopmental Disorders, run by Universidad de Murcia at 1 site in Spain.
Trial summary
The prospective multicenter study GD-Brain provides a better knowledge on the basis of neurological impairment in children born to mothers with gestational diabetes (GDM). GDM modifies placental structure and affect materno-fetal nutrient transfer. Read more about this study
- Who is it for?
- Ages 8 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus in Childbirth, Neurodevelopmental Disorders
- How many people
- 174 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2016to Dec 2020
- Phase
- Observational
- 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 8 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 174 Children born between 2008-2011 from 2 previous studies: * PREOBE study from the University of Granada * GDM Murcia study from the University of Murcia
Who may be able to join
- Children from healthy pregnancies and GDM pregnancies from the ^PREOBE study and GDM Murcia study.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Elvira Larqué
Murcia, Murcia, 30100
Elvira Larqué, Dr, 0034868884239, elvirada@um.es
Cristina Campoy, MD, 0034958240740, ccampoy@ugr.es
About this study
Official title: Early Biomarkers of Neurodevelopment in Offspring of Diabetic Mothers (GD-BRAIN)
The prospective multicenter study GD-Brain provides a better knowledge on the basis of neurological impairment in children born to mothers with gestational diabetes (GDM). GDM modifies placental structure and affect materno-fetal nutrient transfer. Docosahexaenoic acid (DHA) play an important role on neurodevelopment, and it is reduced in venous cord blood of newborns born to GDM. In previous studies, we have already demonstrated impaired DHA fetal levels not only using label fatty acids with stable isotopes administrated to pregnant women, but also in observational studies in GDM as the prevention of obesity study (PREOBE study) in Granada and other similar study in Murcia. The impaired cord DHA levels were associated to disturbed neurodevelopment in these children during the first year of life. However, it is uncertain the mechanisms underlying this impaired materno-fetal DHA transfer and implications for later life.
The recent publication in Nature Journal of a selective transmembrane carrier for DHA in brain named "major facilitator superfamily domain 2a" (MFSD2a) open new expectations. We detected disturbed MFSD2a levels in placentas from GDM which could be due to structural problems in this organ; inflammation, oxidation and metabolic changes related to diabetes might affect MFSD2a activity. Moreover, it is difficult to know whether disturbed MFSD2a levels in placenta may also indicate altered levels of this carrier in the brain from children born to GDM mothers, which could contribute to neurodevelopment impairment in these subjects. Recent studies also indicate that obesity alters the biosynthesis of eicosanoids derived from DHA, with a decrease of protectins and resolvin of D-series, which have powerful anti-inflammatory properties.
The main aim of this study is to analyse potential differences on neurodevelopment, and brain structure and functioning, in children 8 years old born to GDM respect to those born to healthy normoweight mothers, as well as to identify early biomarkers consistently related to neurodevelopment from early stages of life.
Read the detailed description
We will contact to participants from the PREOBE study and Murcia's cohorts study to get involved a total of 174 children at 8 years of age. The results from neurodevelopment evaluation by neuropsychological testing, neurological functions rhythms and neuroimaging (fMRI and DTI) at 8 years old will be associated to clinical and metabolic data recorded during pregnancy.
As secondary aim, we would discern whether the decrease on DHA levels in offspring of GDM at birth is associated to disturbed neurodevelopment at 8 years old.
The impact of maternal diabetes on placental MFSD2a and children's resolvin and protectins derived from DHA will be measured in urine samples at 8 years old.
Gut microbiota composition and function will be also studied to detect its role in the potential disturbances regarding the production of anti-inflammatory mediators.
A part from the clinical study, we will perform an intervention trial using animal models. Gestational rats with diabetes and control rats will be treated with antioxidants and adipoRon in order to delay neuro-degeneration in these animals because of the diabetes, as well as their influence on MFSD2a levels in placenta and brain. All these studies may provide to the industry of valuable information to improve nutritional supplements during gestation or infancy to avoid potential delay of cognitive functions in offspring of diabetic mothers.
- Keywords
- Gestational diabetes, Neurodevelopment, Placenta, Gut microbiota, Protectins, MFSD2a, AdipoRon
- Medical subject headings
- Neurodevelopmental Disorders, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Children at 8 years old born from healthy pregnancies | |
| GDM | Children at 8 years old born from mothers with gestational diabetes during pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological battery
Neuropsychological battery to cover different neuropsychological domains: processing speed, memory, attention, language, executive functions, and behaviour (parent-completed measure).
Measured: 8 years old
Neuroimaging ( functional MRI)
Anatomical magnetic resonance imaging (fMRI)
Measured: 8 years
Electroencephalography (EEG)
Stereotyped electrophysiological response to several external stimulus
Measured: 8 years
Secondary outcomes (2)
Fatty acids
Fatty acid profile in oral mucose
Measured: 8 years old
Metabolomic
Prostaglandins, thromboxans, isoprostanes, resolvin in urine samples
Measured: 8 years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study startJan 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus in ChildbirthStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Granada
- Responsible party
- Principal investigator, Elvira Larqué, Universidad de Murcia
- Investigators
- Elvira Larqué, Dr., Principal investigator, Universidad de MurciaCristina Campoy, MD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032991
- Sponsor's protocol ID
- SAF2015-69265
- Acronym
- GD-BRAIN
- Status last verified
- Jan 2017
- First submitted
- 13 Jan 2017
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Biomarkers of Neurodevelopment in Offspring of Diabetic Mothers (GD-BRAIN)
- ClinicalTrials.gov ID
- NCT03032991
- Acronym / sponsor ID
- GD-BRAIN / SAF2015-69265
- Keywords
- Gestational diabetes, Neurodevelopment, Placenta, Gut microbiota, Protectins, MFSD2a, AdipoRon
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Collaborators
- Universidad de Granada
- Study start
- Jan 2016
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 26 Jan 2017 (estimated)
- 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.
The prospective multicenter study GD-Brain provides a better knowledge on the basis of neurological impairment in children born to mothers with gestational diabetes (GDM). GDM modifies placental structure and affect materno-fetal nutrient transfer. Docosahexaenoic acid (DHA) play an important role on neurodevelopment, and it is reduced in venous cord blood of newborns born to GDM. In previous studies, we have already demonstrated impaired DHA fetal levels not only using label fatty acids with stable isotopes administrated to pregnant women, but also in observational studies in GDM as the prevention of obesity study (PREOBE study) in Granada and other similar study in Murcia. The impaired cord DHA levels were associated to disturbed neurodevelopment in these children during the first year of life. However, it is uncertain the mechanisms underlying this impaired materno-fetal DHA transfer and implications for later life.
The recent publication in Nature Journal of a selective transmembrane carrier for DHA in brain named "major facilitator superfamily domain 2a" (MFSD2a) open new expectations. We detected disturbed MFSD2a levels in placentas from GDM which could be due to structural problems in this organ; inflammation, oxidation and metabolic changes related to diabetes might affect MFSD2a activity. Moreover, it is difficult to know whether disturbed MFSD2a levels in placenta may also indicate altered levels of this carrier in the brain from children born to GDM mothers, which could contribute to neurodevelopment impairment in these subjects. Recent studies also indicate that obesity alters the biosynthesis of eicosanoids derived from DHA, with a decrease of protectins and resolvin of D-series, which have powerful anti-inflammatory properties.
The main aim of this study is to analyse potential differences on neurodevelopment, and brain structure and functioning, in children 8 years old born to GDM respect to those born to healthy normoweight mothers, as well as to identify early biomarkers consistently related to neurodevelopment from early stages of life.
Detailed description
We will contact to participants from the PREOBE study and Murcia's cohorts study to get involved a total of 174 children at 8 years of age. The results from neurodevelopment evaluation by neuropsychological testing, neurological functions rhythms and neuroimaging (fMRI and DTI) at 8 years old will be associated to clinical and metabolic data recorded during pregnancy.
As secondary aim, we would discern whether the decrease on DHA levels in offspring of GDM at birth is associated to disturbed neurodevelopment at 8 years old.
The impact of maternal diabetes on placental MFSD2a and children's resolvin and protectins derived from DHA will be measured in urine samples at 8 years old.
Gut microbiota composition and function will be also studied to detect its role in the potential disturbances regarding the production of anti-inflammatory mediators.
A part from the clinical study, we will perform an intervention trial using animal models. Gestational rats with diabetes and control rats will be treated with antioxidants and adipoRon in order to delay neuro-degeneration in these animals because of the diabetes, as well as their influence on MFSD2a levels in placenta and brain. All these studies may provide to the industry of valuable information to improve nutritional supplements during gestation or infancy to avoid potential delay of cognitive functions in offspring of diabetic mothers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Children at 8 years old born from healthy pregnancies |
| GDM | – | –Children at 8 years old born from mothers with gestational diabetes during pregnancy |
Who may qualify
- Ages
- 8 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 174 Children born between 2008-2011 from 2 previous studies: * PREOBE study from the University of Granada * GDM Murcia study from the University of Murcia
Key inclusion criteria (1 listed)
- Children from healthy pregnancies and GDM pregnancies from the ^PREOBE study and GDM Murcia study.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neuropsychological battery
Time frame: 8 years old
Neuropsychological battery to cover different neuropsychological domains: processing speed, memory, attention, language, executive functions, and behaviour (parent-completed measure).
Neuroimaging ( functional MRI)
Time frame: 8 years
Anatomical magnetic resonance imaging (fMRI)
Electroencephalography (EEG)
Time frame: 8 years
Stereotyped electrophysiological response to several external stimulus
2 secondary outcomes
Fatty acids
Time frame: 8 years old
Metabolomic
Time frame: 8 years old
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
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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.
Elvira Larqué, Dr. principal investigator
Universidad de Murcia
Cristina Campoy, MD principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes Mellitus in Childbirth and Neurodevelopmental Disorders, run by Universidad de Murcia at 1 site in Spain.
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 1 inclusion and 1 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 26 Jan 2017. 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 Spain. 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?
Contact Elvira Larqué, Dr (0034868884239, elvirada@um.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological battery (time frame: 8 years old). The study lists 3 primary outcomes in all. 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 26 Jan 2017.