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Screening strategies for early detection of pre-diabetes and undiagnosed type 2 diabetes
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注册号:

Registration number:

ChiCTR-OCS-14004457 

最近更新日期:

Date of Last Refreshed on:

2016-08-28 

注册时间:

Date of Registration:

2014-04-04 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

釐定糖尿病前期和未確診的二型糖尿病篩查策略 

Public title:

Screening strategies for early detection of pre-diabetes and undiagnosed type 2 diabetes 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

釐定糖尿病前期和未確診的二型糖尿病篩查策略 

Scientific title:

Determining screening strategies for early detection of pre-diabetes and undiagnosed type 2 diabetes among Hong Kong Chinese aged 35 to 65 years 

研究课题代号(代码):

Study subject ID:

CRE-2014.018 

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:

CUHK_CCT00400 

申请注册联系人:

Prof. Chair Sek Ying 

研究负责人:

Prof. Chair Sek Ying 

Applicant:

Prof. Chair Sek Ying 

Study leader:

Prof. Chair Sek Ying 

申请注册联系人电话:

Applicant telephone:

+852 39436225 

研究负责人电话:

Study leader's telephone:

+852 39436225 

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:

sychair@cuhk.edu.hk 

研究负责人电子邮件:

Study leader's E-mail:

sychair@cuhk.edu.hk 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

https://www2.ccrb.cuhk.edu.hk/registry/public/239 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

https://www2.ccrb.cuhk.edu.hk/registry/public/239 

申请注册联系人通讯地址:

Rm 825, 8/F, Esther Lee Building, Chinese University of Hong Kong, Shatin, N.T. 

研究负责人通讯地址:

Rm 825, 8/F, Esther Lee Building, Chinese University of Hong Kong, Shatin, N.T. 

Applicant address:

Rm 825, 8/F, Esther Lee Building, Chinese University of Hong Kong, Shatin, N.T. 

Study leader's address:

Rm 825, 8/F, Esther Lee Building, Chinese University of Hong Kong, Shatin, N.T. 

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:

The Chinese University of Hong Kong 

Applicant's institution:

The Chinese University of Hong Kong 

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:

NA 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

The Chinese University of Hong Kong 

Name of the ethic committee:

The Chinese University of Hong Kong 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-03-10 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

The Nethersole School of Nursing, The Chinese University of Hong Kong 

Primary sponsor:

The Nethersole School of Nursing, The Chinese University of Hong Kong 

研究实施负责(组长)单位地址:

The Nethersole School of Nursing, The Chinese University of Hong Kong 

Primary sponsor's address:

The Nethersole School of Nursing, The Chinese University of Hong Kong 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

香港特別行政區

市(区县):

Country:

China

Province:

Hong Kong SAR

City:

单位(医院):

The Chinese University of Hong Kong

具体地址:

Rm 825, 8/F, Esther Lee Building, Chinese University of Hong Kong, Shatin, N.T.

Institution
hospital:

The Chinese University of Hong Kong

Address:

Rm 825, 8/F, Esther Lee Building, Chinese University of Hong Kong, Shatin, N.T.

经费或物资来源:

Gereral Research Fund applied and result will be notified on June 2014 

Source(s) of funding:

Gereral Research Fund applied and result will be notified on June 2014 

研究疾病:

Diabetes 

Target disease:

Diabetes 

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:

IV期临床试验 

Study phase:

研究目的:

To determine screening strategies for early detection of pre-diabetes and undiagnosed type 2 diabetes among Hong Kong Chinese aged 35 to 65 years 

Objectives of Study:

To determine screening strategies for early detection of pre-diabetes and undiagnosed type 2 diabetes among Hong Kong Chinese aged 35 to 65 years 

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. Aged between 35 and 65 years; 2. Chinese ethnicity; 3. No history of any type of diabetes; 4. Able and willing to give informed written consent. 

Inclusion criteria

1. Aged between 35 and 65 years; 2. Chinese ethnicity; 3. No history of any type of diabetes; 4. Able and willing to give informed written consent. 

排除标准:

1. Diagnosed with diabetes mellitus; 2. Unable to complete a questionnaire interview; 3. Unable to undergo a standard 75g oral glucose tolerance test in the designated clinic. 

Exclusion criteria:

1. Diagnosed with diabetes mellitus; 2. Unable to complete a questionnaire interview; 3. Unable to undergo a standard 75g oral glucose tolerance test in the designated clinic. 

研究实施时间:

Study execute time:

From2014-09-01To  

干预措施:

Interventions:

组别:

1

样本量:

2400

Group:

1

Sample size:

干预措施:

NA

干预措施代码:

Intervention:

NA

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

香港特別行政區 

市(区县):

 

Country:

China 

Province:

Hong Kong SAR 

City:

 

单位(医院):

The Nethersole School of Nursing, The Chinese University of Hong Kong 

单位级别:

The Nethersole School of Nursing, The Chinese University of Hong Kong 

Institution
hospital:

The Nethersole School of Nursing, The Chinese University of Hong Kong  

Level of the institution:

The Nethersole School of Nursing, The Chinese University of Hong Kong 

测量指标:

Outcomes:

指标中文名:

The most cost-effect diabetes screening strategy identify pre-diabetes and undiagnosed type 2 diabetes will be developed based on the collected data

指标类型:

主要指标 

Outcome:

The most cost-effect diabetes screening strategy identify pre-diabetes and undiagnosed type 2 diabetes will be developed based on the collected data

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:

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 35 years
最大 Max age 65 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):

Not a RCT

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

Not a RCT

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

Not stated

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

Not stated

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:

Not stated

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

Not stated

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2014-04-04
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