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农村60岁及以上2型糖尿病前期人群社区综合干预模式及卫生经济学评价
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注册号:

Registration number:

ChiCTR-IOR-15007033 

最近更新日期:

Date of Last Refreshed on:

2015-09-09 

注册时间:

Date of Registration:

2015-08-10 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

农村60岁及以上2型糖尿病前期人群社区综合干预模式及卫生经济学评价 

Public title:

The community-based comprehensive intervention model on prediabetes of type 2 diabetes of above 60 years people in rural areas its health economic evaluation 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

农村60岁及以上2型糖尿病前期人群社区综合干预模式及卫生经济学评价 

Scientific title:

The community-based comprehensive intervention model on prediabetes of type 2 diabetes of above 60 years people in rural areas its health economic evaluation 

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:

秦露露 

研究负责人:

秦露露 

Applicant:

Qin Lulu 

Study leader:

Qin Lulu 

申请注册联系人电话:

Applicant telephone:

+86 13687338659 

研究负责人电话:

Study leader's telephone:

+86 13687338659 

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:

705470465@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

705470465@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:

湖南省长沙市开福区上麻园岭238号中南大学公共卫生学院 

研究负责人通讯地址:

湖南省长沙市开福区上麻园岭238号中南大学公共卫生学院 

Applicant address:

238 Shangmayuanling Road, Kaifu District, Changsha, China 

Study leader's address:

238 Shangmayuanling Road, Kaifu District, Changsha, 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:

中南大学 

Applicant's institution:

Central South 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:

ctxy-15000j-7 

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:

中南大学临床药理研究所医学伦理委员会 

Name of the ethic committee:

medical ethics committee of the institute of clinical pharmacology of central south university 

伦理委员会批准日期:

Date of approved by ethic committee:

2015-02-27 

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:

中南大学 

Primary sponsor:

central south university 

研究实施负责(组长)单位地址:

长沙市开福区上麻园岭238号 

Primary sponsor's address:

238 Shangmayuanling Road, Kaifu District, Changsha, 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):

湖南

市(区县):

Country:

China

Province:

Hunan

City:

单位(医院):

中南大学

具体地址:

长沙市开福区上麻园岭238号

Institution
hospital:

Central South University

Address:

238 Shangmayuanling Road, Kaifu District, Changsha, China

经费或物资来源:

中南大学教师基金 

Source(s) of funding:

the teachers fund of central south university 

研究疾病:

糖尿病前期 

Target disease:

prediabetes 

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:

其它 

Study phase:

N/A 

研究目的:

本研究拟首次在中国农村社区建立高效的、切实可行的基于社区、家庭、个人的糖尿病高危人群的综合干预模式. 

Objectives of Study:

This study is to establish an effective feasible individual-family-community comprehensive intervention model in rural community in china. 

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:

①经ogtt试验诊断符合糖尿病前期诊断标准;②年龄在60岁及以上;③具有当地户口且近3年来居住在当地的常住居民;④自愿参加本研究。 

Inclusion criteria

1. people diagnoed as prediabetes by ogtt; 2. patients aged 60 years above; 3. patients who had achieved registered permanent residence lived for more than 3 years recent years; 4. signed informed consent form. 

排除标准:

①已确诊为糖尿病患者;②符合糖尿病的诊断标准;③有严重躯体疾病、听知觉障碍、意识障碍等不适宜参加本次研究者。 

Exclusion criteria:

1. diabetes; 2. new diagnosed diabetes; 3. people with severe physical or mental illness. 

研究实施时间:

Study execute time:

From2015-04-01To  

征募观察对象时间:

Recruiting time:

From2015-04-01To  

干预措施:

Interventions:

组别:

干预组

样本量:

200

Group:

intervetion group

Sample size:

干预措施:

综合干预

干预措施代码:

Intervention:

Comprehensive intervention

Intervention code:

组别:

对照组

样本量:

200

Group:

control group

Sample size:

干预措施:

干预措施代码:

Intervention:

none

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖南 

市(区县):

 

Country:

China 

Province:

Hunan 

City:

 

单位(医院):

中南大学 

单位级别:

university 

Institution
hospital:

Central South University  

Level of the institution:

university 

测量指标:

Outcomes:

指标中文名:

血糖

指标类型:

主要指标 

Outcome:

Blood 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:

总胆固醇

指标类型:

次要指标 

Outcome:

Total cholesterol

Type:

Secondary 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:

次要指标 

Outcome:

Triglyceride

Type:

Secondary 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:

次要指标 

Outcome:

High density lipoprotein

Type:

Secondary 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:

次要指标 

Outcome:

Low density lipoprotein

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

糖化血糖蛋白

指标类型:

次要指标 

Outcome:

Glycosylated blood glucose

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:

征募研究对象情况:

Recruiting status:

结束

Completed

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):

随机数字表

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

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):

是否共享原始数据:

IPD sharing

否No

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:

 2015-08-10
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