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淮安市糖尿病防治方案研究
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注册号:

Registration number:

ChiCTR-TRC-14005029 

最近更新日期:

Date of Last Refreshed on:

2014-12-07 

注册时间:

Date of Registration:

2014-07-29 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

淮安市糖尿病防治方案研究 

Public title:

Diabetes prevention programme in Huaian 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

淮安市糖尿病防治方案研究 

Scientific title:

Diabetes prevention programme in Huaian 

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:

胡文 

研究负责人:

俞伟男 

Applicant:

HU WEN 

Study leader:

YU WEINAN 

申请注册联系人电话:

Applicant telephone:

+86 15189658236 

研究负责人电话:

Study leader's telephone:

+86 13951265638 

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:

huwen787878@163.com 

研究负责人电子邮件:

Study leader's E-mail:

452300365@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:

江苏省淮安市淮海南路60号 

研究负责人通讯地址:

江苏省淮安市淮海南路60号 

Applicant address:

60 Huaihai south road, Huaian, Jiangsu 

Study leader's address:

60 Huaihai south road, Huaian, Jiangsu 

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:

淮安市第二人民医院 

Applicant's institution:

Huaian Second People's Hospital 

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:

20130926 

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:

淮安市第二人民医院伦理委员会 

Name of the ethic committee:

the second people's hospital ethics committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-09-26 

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:

淮安市第二人民医院 

Primary sponsor:

Huaian Second People's Hospital 

研究实施负责(组长)单位地址:

江苏省淮安市淮海南路60号 

Primary sponsor's address:

60 Huaihai south road, Huaian, Jiangsu 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

江苏

市(区县):

Country:

China

Province:

Jiangsu

City:

单位(医院):

淮安市第二人民医院

具体地址:

江苏省淮安市淮海南路60号

Institution
hospital:

Huaian Second People's Hospital

Address:

60 Huaihai south road, Huaian, Jiangsu

经费或物资来源:

江苏省卫生厅 

Source(s) of funding:

The Jiangsu health department 

研究疾病:

糖尿病 

Target disease:

diabetes 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

临床预试验 

Study phase:

Clinical pre-test 

研究目的:

1、通过系统规范化的管理,使得2型糖尿病的发生率和患病率显著下降。 2、研究探索出淮安市糖尿病防治的适宜模式,以便在全市范围全面推广,并在其它慢性病的防治中借鉴推广。 

Objectives of Study:

1. through the standardization of the management system, making a significant reduction in the incidence and prevalence of type 2 diabetes; 2. the research explored on the suitable mode of prevention and control of diabetes, so that comprehensive promotion throughout the whole city, and in other chronic diseases prevention and control of reference. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

在社保中心参加统一管理的退休职工中选择血糖异常的糖尿病人和糖耐量异常人群作为研究观察对象。 

Inclusion criteria

In the social security center to take part in the unified administration of retired worker choose abnormal blood sugar diabetes and abnormal glucose tolerance people as study object. 

排除标准:

严重的肝肾功能不全患者,心肌梗塞、脑血管意外急性期,行为沟通障碍者。 

Exclusion criteria:

Severe patients with liver and kidney dysfunction, acute phase of myocardial infarction, cerebrovascular accident, communication behavior disorder. 

研究实施时间:

Study execute time:

From2012-12-31To 2015-09-01 

干预措施:

Interventions:

组别:

A

样本量:

200

Group:

A

Sample size:

干预措施:

糖尿病教育

干预措施代码:

Intervention:

diabetes education

Intervention code:

组别:

B

样本量:

200

Group:

B

Sample size:

干预措施:

糖尿病教育、药物指导

干预措施代码:

Intervention:

Diabetes education and guidance

Intervention code:

组别:

C

样本量:

200

Group:

C

Sample size:

干预措施:

药物指导

干预措施代码:

Intervention:

Drag guidance

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

淮安市第二人民医院 

单位级别:

三甲 

Institution
hospital:

Huaian second people‘s hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

有效控制率

指标类型:

主要指标 

Outcome:

control rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

再住院率

指标类型:

主要指标 

Outcome:

Hospitalization rate

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:

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 45 years
最大 Max age 85 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):

随机对照表

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

A random number table

盲法:

Blinding:

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:

即时公开/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):

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

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:

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

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2014-07-29
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