Gestational DiabetesNCT03165643
The DNA Methylation of ARHGEF11 in Macrosomia
An observational study of Gestational Diabetes and Diabetes, run by Peking University First Hospital.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Gestational Diabetes, Diabetes, Macrosomia, Fetal
- What is being tested?
- OGTT
- How many people
- 239 participants
- Where
- No sites listed yet
- Study dates
- 6 Mar 2014to 18 Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Singleton term pregnant women in Peking University First Hospital were recruited in this study.
Who may be able to join
- -
Who cannot join
- Pregnancies complicating with hypertensive disorders, pre-gestational diabetes, thyroid diseases, renal dysfunction were excluded.
About this study
Official title: Epigenetic Alteration of Rho Guanine Nucleotide Exchange Factor 11 (ARHGEF11) in Cord Blood Samples in Macrosomia Exposed to Intrauterine Hyperglycaemia
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.
- Conditions
- Gestational Diabetes, Diabetes, Macrosomia, Fetal
- Being tested
- OGTT
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus, Fetal Macrosomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OGTTDiagnostic test
75 g glucose tolerance test was provided to all pregnant women during 24-28 weeks.
| Study group | Role | What they receive |
|---|---|---|
| NGT-normal birth weight | Not described | |
| NGT-macrosomia | Not described | |
| GDM-normal birth weight | Not described Receives: Diagnostic Test: OGTT | |
| GDM-macrosomia | Not described Receives: Diagnostic Test: OGTT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24-28 weeks
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.
Measured: 40 weeks
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.
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start6 Mar 2014
- Primary completion18 Oct 2014
- Study completion18 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Yan, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165643
- Sponsor's protocol ID
- 2013572
- Status last verified
- May 2017
- First submitted
- 21 May 2017
- Last updated
- 24 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epigenetic Alteration of Rho Guanine Nucleotide Exchange Factor 11 (ARHGEF11) in Cord Blood Samples in Macrosomia Exposed to Intrauterine Hyperglycaemia
- ClinicalTrials.gov ID
- NCT03165643
- Acronym / sponsor ID
- 2013572
- Conditions
- Gestational Diabetes, Diabetes, Macrosomia, Fetal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 6 Mar 2014 (actual)
- Primary completion
- 18 Oct 2014 (actual)
- Study completion
- 18 Oct 2014 (actual)
- First posted
- 24 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NGT-normal birth weight | – | – |
| NGT-macrosomia | – | – |
| GDM-normal birth weight | – | Diagnostic Test: OGTT |
| GDM-macrosomia | – | Diagnostic Test: OGTT |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Singleton term pregnant women in Peking University First Hospital were recruited in this study.
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- Pregnancies complicating with hypertensive disorders, pre-gestational diabetes, thyroid diseases, renal dysfunction were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OGTT75 g glucose tolerance test was provided to all pregnant women during 24-28 weeks. | Diagnostic test | GDM-macrosomia, GDM-normal birth weight |
Primary outcome
GDM was identified
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes and Diabetes, run by Peking University First Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GDM was identified (time frame: 24-28 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2017.