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

• Conditions: Neurodevelopmental Outcome; Epigenetic Changes; Gestational Diabetes; Pregestational Diabetes; IDM (Infant of Diabetic Mothers)

• Registration Number: NCT01255384
• Lead Sponsor: Hadassah Medical Organization

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-12
• Study Start: 2010-12
• Study First Submitted: 2010-12-06
• Study First Submitted QC: 2010-12-06
• Last Update Submitted: 2010-12-06
• Study First Posted: 2010-12-07
• Last Update Posted: 2010-12-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Hadassah Medical Organization, Jerusalem, Israel; 🇮🇱 Jerusalem, Israel