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

NCT01255384 | Unknown

• 1 other identifier: EPI-DIABETES-HMO-CTIL
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Study Arms (2)

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 Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Infants born to women suffering from pre-gestational or gestational diabetes.

You may not qualify if:

• Non Jewish population
• Triplets and up
• Premature infants under 32 weeks
• Infants suffering from major congenital anomalies
• Infants with chromosomal aberrations

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Placental biopsy cord bloos Saliva

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Asher Ornoi, MD

  Hadassah Medical Organization

  STUDY DIRECTOR

Central Study Contacts

Asher Ornoy, MD

CONTACT

0097226758329; ornoy@cc.huji.ac.il

Zivanit Ergaz Shaltiel, MD

CONTACT

00972507874285; zivanit@hadassah.org.il

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 6, 2010
• First Posted: December 7, 2010
• Study Start: December 1, 2010
• Last Updated: December 7, 2010

Record last verified: 2010-12

Locations

IL (1)