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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Non Diabetic-Controls

Pregnant women with uncomplicated pregnancy will be followed, their offsprings will be evaluated and followed for 5 years

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Laboratory of Teratology, Israel Canada Institute of Medical Research, Hebrew University Hadassah Medical School, Jerusalem, Israel.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Asher Ornoi, MD

Role: STUDY_DIRECTOR

Hadassah Medical Organization

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Asher Ornoy, MD

Role: CONTACT

Phone: 0097226758329

Email: [email protected]

Zivanit Ergaz Shaltiel, MD

Role: CONTACT

Phone: 00972507874285