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Study on the biological characteristics of Prokineticin 2 in circulation in obese children
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注册号:

Registration number:

ChiCTR2000038838 

最近更新日期:

Date of Last Refreshed on:

2020-12-27 

注册时间:

Date of Registration:

2020-10-05 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

Prokineticin 2在单纯性肥胖儿童血液循环中的生物学特性研究 

Public title:

Study on the biological characteristics of Prokineticin 2 in circulation in obese children 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

Prokineticin 2在单纯性肥胖儿童血液循环中的生物学特性研究 

Scientific title:

Study on the biological characteristics of Prokineticin 2 in circulation in obese children 

研究课题代号(代码):

Study subject ID:

 

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:

王寒 

研究负责人:

王寒 

Applicant:

Han Wang 

Study leader:

Han Wang 

申请注册联系人电话:

Applicant telephone:

+86 18323187902 

研究负责人电话:

Study leader's telephone:

+86 18323187902 

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:

wanghanberyl@163.com 

研究负责人电子邮件:

Study leader's E-mail:

wanghanberyl@163.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:

重庆市渝中区中山二路136号 

研究负责人通讯地址:

重庆市渝中区中山二路136号 

Applicant address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, China 

Study leader's address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

重庆医科大学附属儿童医院 

Applicant's institution:

Children's Hospital of Chongqing Medical 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:

(2020)年伦审(研)第(184)号 

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:

重庆医科大学附属儿童医院医学研究伦理委员会 

Name of the ethic committee:

Institutional Review Board of Children's Hospital of Chongqing Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-06-30 

伦理委员会联系人:

卢仲毅 

Contact Name of the ethic committee:

Zhongyi Lu 

伦理委员会联系地址:

重庆市渝中区中山二路136号 

Contact Address of the ethic committee:

136 Second Zhongshan Road, Yuzhong District, Chongqing, 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:

重庆医科大学附属儿童医院 

Primary sponsor:

Children's Hospital of Chongqing Medical University 

研究实施负责(组长)单位地址:

重庆市渝中区中山二路136号 

Primary sponsor's address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, 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):

重庆

市(区县):

Country:

China

Province:

Chognqing

City:

单位(医院):

重庆医科大学附属儿童医院

具体地址:

渝中区中山二路136号

Institution
hospital:

Children's Hospital of Chongqing Medical University

Address:

136 Second Zhongshan Road, Yuzhong District

经费或物资来源:

自筹 

Source(s) of funding:

self-finance 

研究疾病:

儿童肥胖 

Target disease:

Childhood Obesity 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

研究肥胖和正常体重儿童血清Prokineticin 2水平及其与代谢参数之间的潜在关系。 

Objectives of Study:

To investigate serum Prokineticin 2 levels and the potential relationship between PK2 and metabolic parameters in obese and normal-weight children.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

对照组从体检中心常规体检者中选取。根据《中国0-18岁儿童体重指数(BMI)增长参考》,定义肥胖儿童为体重指数(BMI)大于适宜年龄和性别的95%。 

Inclusion criteria

The control subjects were selected from routine medical check-up at the Department of Physical Examination Center. The obese children was defined as body mass index (BMI) greater than the 95th percentile of the appropriate age and gender, according to BMI growth reference for Chinese children aged 0-18 years. 

排除标准:

遗传性或内分泌型肥胖;使用甲状腺素片、地塞米松、甲双胍等代谢性药物;肝肾疾病;癌症;新近感染;任何可能影响参与研究的医学或精神疾病。 

Exclusion criteria:

Genetic or endocrine obesity; using metabolic drugs such as thyroxine tablets, dexamethasone, metaformin; hepatic or renal disease; cancers; recent infection; any medical or mental disease that would interfere with the study participation. 

研究实施时间:

Study execute time:

From2020-10-10To 2022-07-31 

征募观察对象时间:

Recruiting time:

From2020-10-10To 2022-01-31 

干预措施:

Interventions:

组别:

正常体重组VS肥胖儿童组

样本量:

200

Group:

Normal weight group vs obese group

Sample size:

干预措施:

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆医科大学附属儿童医院 

单位级别:

三甲 

Institution
hospital:

Children’s Hospital of Chongqing Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

身高

指标类型:

主要指标 

Outcome:

Height

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体重

指标类型:

主要指标 

Outcome:

Weight

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

葡萄糖

指标类型:

主要指标 

Outcome:

Glucose

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胰岛素

指标类型:

主要指标 

Outcome:

Insulin

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

甘油三酯

指标类型:

主要指标 

Outcome:

triglyceride

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总胆固醇

指标类型:

主要指标 

Outcome:

total cholesterol

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

高密度脂蛋白

指标类型:

主要指标 

Outcome:

high-density lipoprotein

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

低密度脂蛋白

指标类型:

主要指标 

Outcome:

low-density lipoprotein

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

前动力蛋白2

指标类型:

主要指标 

Outcome:

prokineticin 2

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白介素-6

指标类型:

主要指标 

Outcome:

interleukin-6

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肿瘤坏死因子-α

指标类型:

主要指标 

Outcome:

tumor necrosis factor-α

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

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

-80℃保存1年

Fate of sample:

Preservation after use 

Note:

Stored at -80℃ for 1 year

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

不适用

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

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

Yes

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):

试验完成后共享于网络平台:中国临床试验注册中心;网址:http://www.chictr.org.cn

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

sharing metadata and protocol 6 months after the trial complete at: http://www.chictr.org.cn

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:

电子采集和管理系统:ResMan

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

Electronic Data Capture, EDC:ResMan

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2020-10-05
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