Possible Epigenetic Changes in Offspring of Women With Pregestational and Gestational Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01255384
First received: December 6, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted

December 6, 2010
December 6, 2010
December 2010
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No Changes Posted
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Possible Epigenetic Changes in Offspring of Women With Pregestational and Gestational Diabetes
Possible Epigenetic Changes in Offspring of Women With Pregestational and Gestational Diabetes: Molecular Studies of the Placenta and Cord Blood and Possible Correlation to Postnatal Development.

Pregestational diabetes (PGD) during pregnancy may be associated with an increased rate of spontaneous abortions, intrauterine death and congenital anomalies among the offspring. Although the prevalence of congenital anomalies among the offspring of diabetic mothers is reduced as a result of the improvement of the glycemic control in the early pregnancy, the rate of congenital anomalies is increased and there seems to be an increased rate of neurodevelopmental disorders including some fine and gross motor deficits as well as increased rate of inattention and/or hyperactivity. In gestational diabetes, that develops in the second half of pregnancy (past the period of major organogenesis), there seems to be no increase in the rate of major congenital anomalies but there are some developmental disorders in the offspring.

The exposure of the developing embryo and fetus to diabetic environment (i.e. hyperglycemia, hyperketonemia ext), is known to cause increased oxidative stress and significant changes in gene expression as observed in several experimental diabetic models. We hypothesize that diabetic environment may also cause long lasting epigenetic changes. It is therefore our purpose to evaluate these possible epigenetic changes and correlate their presence with the degree and time of onset of diabetes, (i.e. whether from the beginning as in PGD or in the second half of pregnancy as in GD), the degree of oxidative stress and with the neurodevelopmental outcome of the offspring. Diabetic pregnancies will be compared to a similar number of normal pregnancies in all parameters studied.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

Placental biopsy cord bloos Saliva

Non-Probability Sample

Infants of diabetic mothers. The follow-up will start at the high risk pregnancy clinic. The obstetrician will follow women with pre-gestational and gestational diabetes. The neonates will be evaluated and followed for epigenetic changes and neurodevelopmental outcome

  • Gestational Diabetes
  • Pregestational Diabetes
  • IDM (Infant of Diabetic Mothers)
  • Neurodevelopmental Outcome
  • Epigenetic Changes
Not Provided
  • Non Diabetic-Controls
    Pregnant women with uncomplicated pregnancy will be followed, their offsprings will be evaluated and followed for 5 years
  • Diabetic Pregnancy
    Pregnant women followed in the high risk clinic because of diabetes will be followed and their offspring's will be evaluated and followed for 5 years
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
300
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Inclusion Criteria:

  • Infants born to women suffering from pre-gestational or gestational diabetes.

Exclusion Criteria:

  • Non Jewish population
  • Triplets and up
  • Premature infants under 32 weeks
  • Infants suffering from major congenital anomalies
  • Infants with chromosomal aberrations
Both
Not Provided
Yes
Contact: Asher Ornoy, MD 0097226758329 ornoy@cc.huji.ac.il
Contact: Zivanit Ergaz Shaltiel, MD 00972507874285 zivanit@hadassah.org.il
Israel
 
NCT01255384
EPI-DIABETES-HMO-CTIL
No
Prof. Asher Ornoy, Laboratory of Teratology, Israel Canada Institute of Medical Research, Hebrew University Hadassah Medical School, Jerusalem, Israel.
Hadassah Medical Organization
Not Provided
Study Director: Asher Ornoi, MD Hadassah Medical Organization
Hadassah Medical Organization
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP