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妊娠期糖尿病孕妇孕期肠道菌群变化特征
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注册号:

Registration number:

ChiCTR1900020652 

最近更新日期:

Date of Last Refreshed on:

2019-01-11 

注册时间:

Date of Registration:

2019-01-11 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

妊娠期糖尿病孕妇孕期肠道菌群变化特征 

Public title:

Dynamics gut microbiome in the development of gestational diabetes mellitus 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

妊娠期糖尿病孕妇孕期肠道菌群变化特征 

Scientific title:

Dynamics gut microbiome in the development of gestational diabetes mellitus 

研究课题代号(代码):

Study subject ID:

国家自然科学基金(81773535) 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

马淑娟 

研究负责人:

谭红专 

Applicant:

Ma Shujuan 

Study leader:

Tan Hongzhuan 

申请注册联系人电话:

Applicant telephone:

+86 13570502166 

研究负责人电话:

Study leader's telephone:

+86 086-731-88858435 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

790039940@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

tanhz99@qq.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

湖南省长沙市开福区上麻园岭巷238号 

研究负责人通讯地址:

湖南省长沙市开福区上麻园岭巷238号 

Applicant address:

238 Shangmayuanling Lane, Kaifu District, Changsha, Hu'nan, China 

Study leader's address:

238 Shangmayuanling Lane, Kaifu District, Changsha, Hu'nan, China 

申请注册联系人邮政编码:

Applicant postcode:

410008 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

中南大学 

Applicant's institution:

Central South University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

EC201624 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

湖南省妇幼保健院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Hunan Maternal and Child Health Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-01-11 

伦理委员会联系人:

谢琼 

Contact Name of the ethic committee:

Xie Qiong 

伦理委员会联系地址:

湖南省长沙市开福区湘春路53号 

Contact Address of the ethic committee:

53 Xiangchun Road, Kaifu District, Changsha, Hu'nan, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

中南大学 

Primary sponsor:

Central South University 

研究实施负责(组长)单位地址:

湖南省长沙市开福区上麻园岭巷238号 

Primary sponsor's address:

238 Shangmayuanling Lane, Kaifu District, Changsha, Hu'nan, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

湖南

市(区县):

长沙

Country:

China

Province:

Hu'nan

City:

Changsha

单位(医院):

湖南省妇幼保健院

具体地址:

湘春路53

Institution
hospital:

Hunan Provincial Maternal and Child Health Hospital

Address:

53 Xiangchun Road

经费或物资来源:

国家自然科学基金(81773535) 

Source(s) of funding:

National Natural Science Foundation of China (81773535) 

研究疾病:

妊娠期糖尿病 

Target disease:

Gestational diabetes mellitus 

研究疾病代码:

 

Target disease code:

 

研究类型:

病因学/相关因素研究 

Study type:

Cause/Relative factors study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

妊娠期糖尿病(GDM)是常见的孕期代谢性疾病,发病率约为16%,并呈逐年升高趋势。GDM不仅会增加母儿不良妊娠结局的发生率,而且还会增加孕妇产后患2型糖尿病(T2DM)、心血管等疾病的风险。GDM和T2DM类似,主要和胰岛素抵抗及胰岛β细胞分泌功能降低有关,但其具体发病机制仍未完全阐明,也无可靠的早期预测模型。现有研究发现孕期肠道菌群会动态改变,且肠道菌群与T2DM及T1DM密切关联;但关于GDM与肠道菌群关系的研究较少,且报告的都是发病时的肠道菌群情况,其确切关系及机理尚难明确。我们假设,肠道菌群可能通过调控宿主代谢,参与GDM的发病与进展。本研究拟通过巢式病例对照研究设计,通过扩增子、宏基因组测序和代谢组学分析技术,探讨GDM发生和发展与肠道菌群动态变化的关系,以及宿主-肠道菌群可能的共代谢机制,以明晰GDM与肠道菌群的关系和机制,并建立以肠道菌群为主要生物标志的GDM早期诊断模型。 

Objectives of Study:

Gestational Diabetes Mellitus (GDM) is a common metabolic disorder during pregnancy, with a prevalence of 16%, which tends to increase annually. GDM can not only increase the morbidity of adverse gestational outcomes of mothers and infants, but also increase the risk of postpartum type 2 Diabetes Mellitus (T2DM), cardiovascular disease as well as other diseases. Similar to T2DM, GDM is related to insulin resistance and dysfunctional incretion of β islets cells. However, the explicit mechanism of its onset has not been elaborated, still, there has not been a reliable early predictive model. Current studies have found dynamic changes in pregnant womens gut microbiome, meanwhile, solid interplays have been found between the effects of gut microbiome and T2DM as well as T1DM. Yet, studies focusing on the relationship between GDM and gut microbiome have rarely been reported, the published ones have just studied the changes in gut microbiome of GDM patients, without dynamic monitoring, which makes it hard to elaborate the explicit relationship and mechanism. The hypothesis is that gut microbiome might have an effect on the hosts metabolism and thus participate in the onset and development of GDM. Thus, this study intends to adopt a nest case-control study, combined with epidemiological survey and techniques of 16S rRNA, metagenome sequencing, metabolomics analysis, to investigate the relationship between dynamic changes of gut microbiome and the development of GDM, meanwhile probing the host- gut microbiome co-metabolism mechanism, which in turn will project light on the relationship between the development of GDM and the dynamics of gut microbiome. In addition, to build an early diagnostic model for GDM based on the changes of gut microbiome as bio-markers, which might provide fundamental evidence for new strategies for the prevention and diagnosis of GDM, with significant theoretical and practical values.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

病例对照研究 

Study design:

Case-Control study 

纳入标准:

(i) 单胎、自然受孕;(ii) 孕早期(10-13+6周)孕妇;(iii) 计划在我们选定的研究现场(湖南省妇幼保健院)完成产检和生产。 

Inclusion criteria

1. singleton pregnancy and natural conception; 2. 10-13+6 week; 3. splanned to complete regular obstetric examinations and the final delivery at current hospital.  

排除标准:

(i)孕前有糖尿病、高血压、甲状腺疾病、或心脑血管等疾病史;(ii) 孕期使用过抗生素;(iii)近2周有急性感染。 

Exclusion criteria:

1. with diseases that might affect microbiome composition or glucose metabolism, like pre-pregnancy diabetes, thyroid disorders, hypertension, inflammatory bowel disease and cardiovascular diseases; 2. had received any antibiotic treatment throughout the current pregnancy; 3. had acute infection within 2 weeks before sample collection. 

研究实施时间:

Study execute time:

From2017-02-20To 2018-12-31 

干预措施:

Interventions:

组别:

妊娠期糖尿病病例组

样本量:

100

Group:

Gestational diabetes mellitus group

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

组别:

对照组

样本量:

900

Group:

Control group

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖南 

市(区县):

长沙 

Country:

China 

Province:

Hu'nan 

City:

Changsha 

单位(医院):

湖南省妇幼保健院 

单位级别:

三甲医院 

Institution
hospital:

Hunan Provincial Maternal and Child Health Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

肠道微生物16S rRNA

指标类型:

主要指标 

Outcome:

16S rRNA of gut microbiome

Type:

Primary indicator 

测量时间点:

测量方法:

16S rRNA测序

Measure time point of outcome:

Measure method:

16S rRNA sequencing

指标中文名:

肠道微生物宏基因组

指标类型:

主要指标 

Outcome:

Metagenome of gut microbiome

Type:

Primary indicator 

测量时间点:

测量方法:

宏基因组测序

Measure time point of outcome:

Measure method:

Metagenome sequencing

指标中文名:

血清代谢谱

指标类型:

主要指标 

Outcome:

Serum metabolism spectrum

Type:

Primary indicator 

测量时间点:

测量方法:

液相色谱-质谱

Measure time point of outcome:

Measure method:

LC/MS

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

标本中文名:

粪便

组织:

Sample Name:

Stool

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 50 years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

该巢式病例对照研究不涉及随机分组。

Randomization Procedure (please state who generates the random number sequence and by what method):

The nested case-control study did not involve randomization.

盲法:

未说明

Blinding:

Not stated

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

研究结果的报告发表

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

Report and publication of the research results

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

数据采集:问卷调查和临床数据电子采集 数据管理:EpiData数据库

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Data collection:Questionnaire survey and Electronic Data Capture Data management: EpiData

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-01-11
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