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Early Biomarkers of Neurodevelopment in Offspring of Diabetic Mothers (GD-BRAIN)

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ClinicalTrials.gov Identifier: NCT03032991
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : January 26, 2017
Sponsor:
Collaborator:
Universidad de Granada
Information provided by (Responsible Party):
Elvira Larqué, Universidad de Murcia

Tracking Information
First Submitted Date January 13, 2017
First Posted Date January 26, 2017
Last Update Posted Date January 26, 2017
Study Start Date January 2016
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 23, 2017)
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 23, 2017)
  • Fatty acids [ Time Frame: 8 years old ]
    Fatty acid profile in oral mucose
  • Metabolomic [ Time Frame: 8 years old ]
    Prostaglandins, thromboxans, isoprostanes, resolvin in urine samples
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 23, 2017)
  • Microbiome [ Time Frame: 8 years old ]
    Metagenome
  • Maturation of circadian rhythm [ Time Frame: 8 years old ]
    Analysis of the circadian rhythm of temperature, activity and sleep
  • Nutritional evaluation [ Time Frame: 8 years old ]
    Dietary assessment by food frequency questionnaire and by 3 day of dietary record
  • Physical activity [ Time Frame: 8 years old ]
    questionnaires
  • Physical Activity [ Time Frame: 8 years old ]
    Accelerometers will be used also to record activity of the subjects
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Early Biomarkers of Neurodevelopment in Offspring of Diabetic Mothers
Official Title Early Biomarkers of Neurodevelopment in Offspring of Diabetic Mothers (GD-BRAIN)
Brief 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. 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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Saliva, urine
Sampling Method Probability Sample
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
Condition
  • Gestational Diabetes Mellitus in Childbirth
  • Neurodevelopmental Disorders
Intervention Not Provided
Study Groups/Cohorts
  • Control
    Children at 8 years old born from healthy pregnancies
  • GDM
    Children at 8 years old born from mothers with gestational diabetes during pregnancy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 23, 2017)
174
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Children from healthy pregnancies and GDM pregnancies from the ^PREOBE study and GDM Murcia study.

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: All
Ages 8 Years to 9 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts
Contact: Elvira Larqué, Dr 0034868884239 elvirada@um.es
Contact: Cristina Campoy, MD 0034958240740 ccampoy@ugr.es
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03032991
Other Study ID Numbers SAF2015-69265
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Elvira Larqué, Universidad de Murcia
Study Sponsor Universidad de Murcia
Collaborators Universidad de Granada
Investigators
Principal Investigator: Elvira Larqué, Dr. Universidad de Murcia
Principal Investigator: Cristina Campoy, MD Universidad de Granada
PRS Account Universidad de Murcia
Verification Date January 2017