Today is 2022-07-07

Environmental Pollutant Exposure and Metabolic Diseases in Shanghai
download

注册号:

Registration number:

ChiCTR1800017573 

最近更新日期:

Date of Last Refreshed on:

2018-08-04 

注册时间:

Date of Registration:

2018-08-04 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

上海浦江两岸环境污染物暴露与糖脂代谢疾病关系研究 

Public title:

Environmental Pollutant Exposure and Metabolic Diseases in Shanghai 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

上海浦江两岸环境污染物暴露与糖脂代谢疾病关系研究 

Scientific title:

Environmental Pollutant Exposure and Metabolic Diseases in Shanghai 

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 School of Medicine 

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:

2017(210) 

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 affiliated to Shanghai Jiaotong University School of Medicine  

伦理委员会批准日期:

Date of approved by ethic committee:

2017-06-30 

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:

上海制造局路639号 

Contact Address of the ethic committee:

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 School of Medicine  

研究实施负责(组长)单位地址:

上海市黄浦区制造局路639号 

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

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:

上海市黄浦区制造局路639号

Institution
hospital:

Shanghai Ninth People's Hospital affiliated to Shanghai Jiaotong University School of Medicine

Address:

639 Zhizaoju Road, Shanghai, China

经费或物资来源:

浦东新区卫生和计划生育委员会重点学科群建设主攻课题 

Source(s) of funding:

Commission of Health and Family Planning of Pudong District 

研究疾病:

代谢性疾病 

Target disease:

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:

1.血铅和镉等于代谢性疾病(糖尿病,肥胖,脂肪肝)的相关性; 2.血铅和镉与糖尿病患者并发症的相关性。 3.维生素D和骨代谢指标与代谢性疾病和糖尿病患者并发症的相关性。 

Objectives of Study:

1. Association between heavy metals such as blood lead and cadmium with metabolic diseases (diabetes, obesity, fatty liver); 2. Association between heavy metals such as blood lead and cadmium and vascular complications in diabetic patients. 3. Association between vitamin D and bone metabolic markers and complications of metabolic diseases and diabetes patients. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

横断面 

Study design:

Cross-sectional 

纳入标准:

1.黄浦区和浦东新区18岁及以上常住人口(居住≥6个月) 2.2型糖尿病患者和非糖尿病人群 

Inclusion criteria

1. Permanent residents, aged older than and equal to 18 years old, living in the Huangpu and Podong district; 2. Diabetic patients and non-diabetic population 

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:

From2018-08-13To 2018-09-28 

征募观察对象时间:

Recruiting time:

From2018-08-13To 2018-09-28 

干预措施:

Interventions:

组别:

One cohort

样本量:

6000

Group:

One cohort

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 

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:

三级甲等 

Institution
hospital:

Shanghai Ninth People's Hospital affiliated to Shanghai Jiaotong University School of Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

血铅

指标类型:

主要指标 

Outcome:

blood lead level

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血镉

指标类型:

主要指标 

Outcome:

blood cadmium level

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

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:

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:

脂肪肝

指标类型:

主要指标 

Outcome:

fatty liver judged by ultrasound

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:

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:

维生素D

指标类型:

主要指标 

Outcome:

vitamin D

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:

次要指标 

Outcome:

lipid profile

Type:

Secondary 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:

尚未开始

Not yet 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):

在每个社区卫生服务中心的管理库中使用简单随机法抽取样本

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

Use a simple random method to sample in the management library of each community health service center

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):

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:

Electronic Data Capture, EDC

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

Electronic Data Capture, EDC

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-08-04
return list