The DNA Methylation of ARHGEF11 in Macrosomia

Diabetes Clinical Trial

Official title:

Epigenetic Alteration of Rho Guanine Nucleotide Exchange Factor 11 (ARHGEF11) in Cord Blood Samples in Macrosomia Exposed to Intrauterine Hyperglycaemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03165643
• Other study ID #: 2013572
• Status: Completed
• Phase: N/A
• First received: May 21, 2017
• Last updated: May 23, 2017
• Start date: March 6, 2014
• Est. completion date: October 18, 2014

Study information

• Verified date: May 2017
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: October 18, 2014
• Est. primary completion date: October 18, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes, Gestational
• Fetal Macrosomia
• Gestational Diabetes
• Macrosomia, Fetal

Intervention

Diagnostic Test:
• OGTT
75 g glucose tolerance test was provided to all pregnant women during 24-28 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GDM was identified	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).	24-28 weeks
Primary	Foetal macrosomia was identified	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.	40 weeks
Primary	DNA methylation level in macrosomia	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.	40 weeks