Viewing Study NCT01255384



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Study NCT ID: NCT01255384
Status: UNKNOWN
Last Update Posted: 2010-12-07
First Post: 2010-12-06

Brief Title: Possible Epigenetic Changes in Offspring of Women With Pregestational and Gestational Diabetes
Sponsor: Hadassah Medical Organization
Organization: Hadassah Medical Organization

Study Overview

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
Status: UNKNOWN
Status Verified Date: 2010-12
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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 andor 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 ie 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 ie 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None