Trial record 7 of 60 for:    Open Studies | "Fetal Diseases"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01255384
First received: December 6, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

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
Gestational Diabetes
Pregestational Diabetes
IDM (Infant of Diabetic Mothers)
Neurodevelopmental Outcome
Epigenetic Changes

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Biospecimen Retention:   Samples Without DNA

Placental biopsy cord bloos Saliva


Estimated Enrollment: 300
Study Start Date: December 2010
Groups/Cohorts
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

  Eligibility

Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01255384

Contacts
Contact: Asher Ornoy, MD 0097226758329 ornoy@cc.huji.ac.il
Contact: Zivanit Ergaz Shaltiel, MD 00972507874285 zivanit@hadassah.org.il

Locations
Israel
Hadassah Medical Organization, Jerusalem, Israel Not yet recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD    00 972 2 6776095    arik@hadassah.org.il   
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
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
Investigators
Study Director: Asher Ornoi, MD Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Prof. Asher Ornoy, Laboratory of Teratology, Israel Canada Institute of Medical Research, Hebrew University Hadassah Medical School, Jerusalem, Israel.
ClinicalTrials.gov Identifier: NCT01255384     History of Changes
Other Study ID Numbers: EPI-DIABETES-HMO-CTIL
Study First Received: December 6, 2010
Last Updated: December 6, 2010
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on August 18, 2014