The DNA Methylation of ARHGEF11 in Macrosomia

Completed

• Conditions: Macrosomia, Fetal; Gestational Diabetes; Diabetes
• Interventions: Diagnostic Test: OGTT

• Registration Number: NCT03165643
• Lead Sponsor: Peking University First Hospital

Brief Summary

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

Not available

Study Timeline

• Study Start: 2014-03-06
• Primary Completion: 2014-10-18
• Study Completion: 2014-10-18
• Status Verified: 2017-05
• Study First Submitted: 2017-05-21
• Study First Submitted QC: 2017-05-23
• Last Update Submitted: 2017-05-23
• Study First Posted: 2017-05-24
• Last Update Posted: 2017-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 239

Inclusion Criteria

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GDM-normal birth weight	OGTT	-
GDM-macrosomia	OGTT	-

Primary Outcome Measures

Name	Time	Method
GDM was identified	24-28 weeks	According to the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria, gestational diabetes mellitus (GDM) was diagnosed when at least one cut point was reached in 2-hour 75-g OGTT test: a fasting plasma glucose (FPG) ≥ 5.1 mmol/L (92 mg/dL), a 1-hour ≥ 10.0 mmol/L (180 mg/dL) or a 2-hour ≥ 8.5 mmol/L (153 mg/dL). Participants were divided into two groups based on OGTT: Group normal glucose tolerant (NGT, n=132) and Group GDM (n=107).
Foetal macrosomia was identified	40 weeks	After delivery, participants were further divided into four subgroups based on neonatal birth weight: normal birth weight (NBW) was defined as 2500g ≤ birth weight \< 4000g, macrosomia (Mac) was defined as birth weight ≥ 4000g. Group NGT-NBW (n=83): normal glucose tolerant women with normal neonatal birth weight; Group NGT-Mac (n=49): normal glucose tolerant women with macrosomia; Group GDM-NBW (n=82): GDM women with normal neonatal birth weight; Group GDM-Mac (n=25): GDM women with macrosomia.
DNA methylation level in macrosomia	40 weeks	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.