今天是:2019-07-21 星期日

中国华东地区代谢性疾病及其危险因素的前瞻性队列研究(二阶段)
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注册号:

Registration number:

ChiCTR1900021356 

最近更新日期:

Date of Last Refreshed on:

2019-02-17 

注册时间:

Date of Registration:

2019-02-17 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中国华东地区代谢性疾病及其危险因素的前瞻性队列研究(二阶段) 

Public title:

Survey for Prevalence in East China for Metabolic Diseases and Risk Factors (Stage 2) 

注册题目简写:

 

English Acronym:

SPECT-China2 

研究课题的正式科学名称:

中国华东地区代谢性疾病及其危险因素的前瞻性队列研究(二阶段) 

Scientific title:

Survey for Prevalence in East China for Metabolic Diseases and Risk Factors (Stage 2) 

研究课题代号(代码):

Study subject ID:

国家自然科学基金重大研究计划(91857117) 

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:

王宁荐 

研究负责人:

陆颖理 

Applicant:

WANG NINGJIAN 

Study leader:

LU YINGLI 

申请注册联系人电话:

Applicant telephone:

+86 13585816216 

研究负责人电话:

Study leader's telephone:

+86 13636352507 

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:

wnj486@126.com 

研究负责人电子邮件:

Study leader's E-mail:

luyingli2008@126.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:

上海市制造局路639号上海第九人民医院2号楼5楼内分泌科  

研究负责人通讯地址:

上海市制造局路639号上海第九人民医院2号楼5楼内分泌科  

Applicant address:

639 Zhizaoju Road, Shanghai, China  

Study leader's address:

639 Zhizaoju Road, Shanghai, 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:

上海交通大学医学院附属第九人民医院 

Applicant's institution:

Shanghai Ninth People's Hospital affiliated to Shanghai Jiaotong 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:

SH9H-2019-T11-1 

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:

上海交通大学医学院附属第九人民医院伦理委员会  

Name of the ethic committee:

Ethics Committee of Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine  

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

甄红 

Contact Name of the ethic committee:

Zhen Hong 

伦理委员会联系地址:

上海市制造局路639号 

Contact Address of the ethic committee:

Shanghai Ninth People's Hospital, 639 Zhizaoju Road, Shanghai, 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:

上海交通大学医学院附属第九人民医院 

Primary sponsor:

Shanghai Ninth People's Hospital affiliated to Shanghai Jiaotong University  

研究实施负责(组长)单位地址:

上海市制造局路639号上海第九人民医院2号楼5楼内分泌科  

Primary sponsor's address:

639 Zhizaoju Road, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海交通大学医学院附属第九人民医院

具体地址:

上海市制造局路639号上海第九人民医院2号楼5楼内分泌科

Institution
hospital:

Shanghai Ninth People's Hospital affiliated to Shanghai Jiaotong University

Address:

Floor 5, Building 2, Endocrinology department, Shanghai Ninth People's Hospital, No. 639 Zhizaoju Road, Shanghai

经费或物资来源:

国家自然科学基金重大研究计划(91857117) 

Source(s) of funding:

the National Natural Science Foundation of China (91857117) 

研究疾病:

内分泌代谢性疾病 

Target disease:

Endocrinology and metabolic diseases 

研究疾病代码:

 

Target disease code:

 

研究类型:

流行病学研究 

Study type:

Epidemilogical research 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

调查代谢性疾病(肥胖,糖代谢疾病,脂肪肝等)中国华东地区的患病率及其危险因素  

Objectives of Study:

To ascertain the current status of the metabolic diseases (obesity, dysglycemia,fatty liver and etc.) and their risk factors.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

在中国华东地区(上海,浙江,江西,江苏,安徽)18岁及以上常住人口(居住≥6个月);曾参与SPECT-China。 

Inclusion criteria

The target population is permanent residents, aged equal to 18 years old and older, living in the administrative divisions directly under control of the central government throughout East China and have participated in SPECT-China1. 

排除标准:

严重交流困难,急性疾病,不愿意参加本研究者 

Exclusion criteria:

Those with severe communication problems, acute illness and unwilling to participate were excluded from the study.  

研究实施时间:

Study execute time:

From2019-02-14To 2023-12-31 

干预措施:

Interventions:

组别:

Population

样本量:

12000

Group:

Population

Sample size:

干预措施:

N/A

干预措施代码:

Intervention:

N/A

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海交通大学医学院附属第九人民医院 

单位级别:

三甲医院 

Institution
hospital:

Shanghai Ninth People's Hospital affiliated to Shanghai Jiaotong University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

糖化血红蛋白

指标类型:

主要指标 

Outcome:

HbA1c

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

空腹血糖

指标类型:

主要指标 

Outcome:

fasting 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:

血脂

指标类型:

主要指标 

Outcome:

serum lipid

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:

肌酐

指标类型:

主要指标 

Outcome:

creatinine

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

黄体生成素

指标类型:

主要指标 

Outcome:

testosterone

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

卵泡刺激素

指标类型:

主要指标 

Outcome:

estrogen

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

促甲状腺素

指标类型:

主要指标 

Outcome:

TSH

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

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:

腰围

指标类型:

主要指标 

Outcome:

waist circumference

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

甲状腺B超

指标类型:

主要指标 

Outcome:

ultrasound results of thyroid

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

脂肪肝

指标类型:

主要指标 

Outcome:

fatty liver judged by ultrasoun

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

黄体生成素

指标类型:

主要指标 

Outcome:

LH

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

卵泡刺激素

指标类型:

主要指标 

Outcome:

FSH

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

臀围

指标类型:

主要指标 

Outcome:

hip circumferenc

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

睾酮

指标类型:

主要指标 

Outcome:

testosterone

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

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

尿液

组织:

Sample Name:

urine

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

粪便

组织:

Sample Name:

stool

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

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 18 years
最大 Max age 90 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):

分层抽样

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

stratified sampling

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

向通讯作者索取

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

contact corresponding author

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:

病例记录表结合电子采集和管理系统。

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

CRF and EDC

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-02-17
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