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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
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.

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
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

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

Biospecimen Retention:   Samples Without DNA
Placental biopsy cord bloos Saliva

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01255384

Contact: Asher Ornoy, MD 0097226758329
Contact: Zivanit Ergaz Shaltiel, MD 00972507874285

Hadassah Medical Organization, Jerusalem, Israel Not yet recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD    00 972 2 6776095   
Contact: Hadas Lemberg, PhD    00 972 2 6777572   
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         
Sponsors and Collaborators
Hadassah Medical Organization
Study Director: Asher Ornoi, MD Hadassah Medical Organization

Responsible Party: Prof. Asher Ornoy, Laboratory of Teratology, Israel Canada Institute of Medical Research, Hebrew University Hadassah Medical School, Jerusalem, Israel. Identifier: NCT01255384     History of Changes
First Posted: December 7, 2010    Key Record Dates
Last Update Posted: December 7, 2010
Last Verified: December 2010

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Fetal Diseases
Pregnancy in Diabetics
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications