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Early Biomarkers of Neurodevelopment in Offspring of Diabetic Mothers

NCT03032991 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 174

Last updated 2017-01-26

No results posted yet for this study

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.

Conditions

  • Gestational Diabetes Mellitus in Childbirth
  • Neurodevelopmental Disorders

Sponsors & Collaborators

  • Universidad de Granada

    collaborator OTHER

  • Universidad de Murcia

    lead OTHER

Principal Investigators

  • Elvira Larqué, Dr. · Universidad de Murcia

  • Cristina Campoy, MD · Universidad de Granada

Eligibility

Min Age
8 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03032991 on ClinicalTrials.gov