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: |
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English Acronym: |
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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: |
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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: |
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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): |
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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: |
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申请人所在单位: |
中南大学 |
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Applicant's institution: |
Central South University |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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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 |
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Name of the ethic committee: |
medical ethics committee of the institute of clinical pharmacology of central south university |
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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: |
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Contact Name of the ethic committee: |
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伦理委员会联系地址: |
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Contact Address of the ethic committee: |
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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 |
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Primary sponsor: |
central south university |
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研究实施负责(组长)单位地址: |
长沙市开福区上麻园岭238号 |
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Primary sponsor's address: |
238 Shangmayuanling Road, Kaifu District, Changsha, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
中南大学教师基金 |
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Source(s) of funding: |
the teachers fund of central south university |
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研究疾病: |
糖尿病前期 |
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Target disease: |
prediabetes |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
其它 | ||||||||||||||||||||||
Study phase: |
N/A |
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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. |
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Objectives of Study: |
This study is to establish an effective feasible individual-family-community comprehensive intervention model in rural community in china. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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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。 |
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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. |
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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。 |
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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: |
从From2015-04-01至To |
征募观察对象时间: Recruiting time: |
从From2015-04-01至To |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
结束 Completed |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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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 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
random number table |
盲法: |
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Blinding: |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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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): |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
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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: |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
暂未确定/Not yet |