The DNA Methylation of ARHGEF11 in Macrosomia

NCT ID: NCT03165643

Last Updated: 2017-05-24

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

COMPLETED

Total Enrollment

239 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-06

Study Completion Date

2014-10-18

Brief Summary

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

Background Macrosomia at birth is associated with subsequent susceptibility to obesity, abnormal glucose metabolism, hypertension and dyslipidaemia. Epigenetic reprogramming has been reported to be involved in the development of human diseases caused by suboptimal environmental or nutritional factors.

Objective The study was aiming to explore epigenetic mechanism influences on macrosomic infants exposed to intrauterine hyperglycemia.

Design The investigators performed a genome-wide analysis of DNA methylation in cord blood from macrosomic infants born to women with gestational diabetes or infants with normal birth weight born to normal glucose-tolerant women in order to identify genes related to foetal growth or early adipose tissue development. The candidate genes were then validated using SEQUENOM MassARRAY after bisulfite conversion.

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 Diabetes Macrosomia, Fetal

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

RETROSPECTIVE

Study Groups

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

NGT-normal birth weight

No interventions assigned to this group

NGT-macrosomia

No interventions assigned to this group

GDM-normal birth weight

OGTT

Intervention Type DIAGNOSTIC_TEST

75 g glucose tolerance test was provided to all pregnant women during 24-28 weeks.

GDM-macrosomia

OGTT

Intervention Type DIAGNOSTIC_TEST

75 g glucose tolerance test was provided to all pregnant women during 24-28 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

OGTT

75 g glucose tolerance test was provided to all pregnant women during 24-28 weeks.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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

Inclusion Criteria

\-

Exclusion Criteria

* Pregnancies complicating with hypertensive disorders, pre-gestational diabetes, thyroid diseases, renal dysfunction were excluded.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

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

Jie Yan

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2013572

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Maternal-fetal Immune Responses to Fetal Surgery
NCT04484441 ACTIVE_NOT_RECRUITING
miRNA in Fetal Overgrowth
NCT01935076 COMPLETED