Possible Epigenetic Changes in Offspring of Women With Pregestational and Gestational Diabetes
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|ClinicalTrials.gov Identifier: NCT01255384|
Recruitment Status : Unknown
Verified December 2010 by Hadassah Medical Organization.
Recruitment status was: Not yet recruiting
First Posted : December 7, 2010
Last Update Posted : December 7, 2010
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.
|Condition or disease|
|Gestational Diabetes Pregestational Diabetes IDM (Infant of Diabetic Mothers) Neurodevelopmental Outcome Epigenetic Changes|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Observational Model:||Case Control|
|Official Title:||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.|
|Study Start Date :||December 2010|
Pregnant women with uncomplicated pregnancy will be followed, their offsprings will be evaluated and followed for 5 years
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01255384
|Contact: Asher Ornoy, MDemail@example.com|
|Contact: Zivanit Ergaz Shaltiel, MDfirstname.lastname@example.org|
|Hadassah Medical Organization, Jerusalem, Israel||Not yet recruiting|
|Contact: Arik Tzukert, DMD 00 972 2 6776095 email@example.com|
|Contact: Hadas Lemberg, PhD 00 972 2 6777572 firstname.lastname@example.org|
|Principal Investigator: Asher Ornoy, MD|
|Principal Investigator: Zivanit Ergaz shaltiel, MD|
|Sub-Investigator: Drorit Hochner, MD|
|Sub-Investigator: Simcha Yagel, MD|
|Sub-Investigator: Uri Elchalal, MD|
|Study Director:||Asher Ornoi, MD||Hadassah Medical Organization|