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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Asher Ornoy, MD; Phone Number: 0097226758329; Email: ornoy@cc.huji.ac.il
• Study Contact Backup: Name: Zivanit Ergaz Shaltiel, MD; Phone Number: 00972507874285; Email: zivanit@hadassah.org.il

Study Locations

• Israel
  • Jerusalem, Israel
    • Hadassah Medical Organization, Jerusalem, Israel
    • Sub-Investigator: Simcha Yagel, MD
    • Principal Investigator: Asher Ornoy, MD
    • Principal Investigator: Zivanit Ergaz shaltiel, MD
    • Sub-Investigator: Drorit Hochner, MD
    • Sub-Investigator: Uri Elchalal, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Investigators: Study Director: Asher Ornoi, MD, Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start: December 1, 2010

Study Registration Dates

• First Submitted: December 6, 2010
• First Submitted That Met QC Criteria: December 6, 2010
• First Posted (Estimate): December 7, 2010

Study Record Updates

• Last Update Posted (Estimate): December 7, 2010
• Last Update Submitted That Met QC Criteria: December 6, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: EPI-DIABETES-HMO-CTIL