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Creatinine Clearance in Diabetes Patients
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注册号:

Registration number:

ChiCTR-OCS-09000344 

最近更新日期:

Date of Last Refreshed on:

2015-05-14 

注册时间:

Date of Registration:

2009-03-06 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

 

Public title:

Creatinine Clearance in Diabetes Patients 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

 

Scientific title:

Estimated Creatinine Clearance 

研究课题代号(代码):

Study subject ID:

51-02-01-0031 

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:

 

研究负责人:

 

Applicant:

Asst. Prof. Dr. Surapon Tangvarasittichai 

Study leader:

Asst. Prof. Dr. Surapon Tangvarasittichai 

申请注册联系人电话:

Applicant telephone:

+66 089 6388382 

研究负责人电话:

Study leader's telephone:

+66 089 6388382 

申请注册联系人传真 :

Applicant Fax:

+66 055 966 241 

研究负责人传真:

Study leader's fax:

+66 055 966 241 

申请注册联系人电子邮件:

Applicant E-mail:

surapon14t@yahoo.com 

研究负责人电子邮件:

Study leader's E-mail:

surapon14t@yahoo.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:

 

研究负责人通讯地址:

 

Applicant address:

Faculty of Allied Health Sciences, Naresuan University, Phitsanulok, Muang, Thailand 

Study leader's address:

Faculty of Allied Health Sciences, Naresuan University, Phitsanulok, Muang, Thailand 

申请注册联系人邮政编码:

Applicant postcode:

65000 

研究负责人邮政编码:

Study leader's postcode:

6500 

申请人所在单位:

 

Applicant's institution:

Faculty of Allied Health Sciences, Naresuan University 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

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:

 

Primary sponsor:

Faculty of Allied Health Sciences, Naresuan University 

研究实施负责(组长)单位地址:

 

Primary sponsor's address:

Faculty of Allied Health Sciences, Naresuan University 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

 

Source(s) of funding:

Faculty of Allied Health Sciences, Naresuan University 

研究疾病:

 

Target disease:

Diabetes mellitus and non-diabetes mellitus. 

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:

其它 

Study phase:

N/A 

研究目的:

 

Objectives of Study:

To evaluate creatinine clearance and estimated creatinine clearance in both diabetes and non-diabetes, and evaluate the association with the other components for early nephropathy detection. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

 

Inclusion criteria

Both type 2 diabetes and non diabetes patients, look healthy, no clinical sign of any organ damage, age >35 years. 

排除标准:

 

Exclusion criteria:

Patients with cardiovascular disease, renal disease, liver disease, age less than 35. 

研究实施时间:

Study execute time:

From2008-03-01To 2009-03-01 

干预措施:

Interventions:

组别:

样本量:

100

Group:

Diabetes group

Sample size:

干预措施:

干预措施代码:

Intervention:

No intervention

Intervention code:

组别:

样本量:

100

Group:

Non Diabetes group

Sample size:

干预措施:

干预措施代码:

Intervention:

No intervention

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

 

省(直辖市):

 

市(区县):

 

Country:

Thailand 

Province:

Muang, Phitsanulok 

City:

 

单位(医院):

 

单位级别:

 

Institution
hospital:

Naresuan University  

Level of the institution:

teaching in B.Sc. student (degree) 

测量指标:

Outcomes:

指标中文名:

指标类型:

主要指标 

Outcome:

estimated ceatinine clearance

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

主要指标 

Outcome:

microalbumin

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

主要指标 

Outcome:

creatinine clearance

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

次要指标 

Outcome:

total Homocysteine

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:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 35 years
最大 Max age 80 years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

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

NA

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):

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

Department of Medical Technology, Faculty of Allied Health Sciences, Naresuan University

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:

Department of Medical Technology

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2009-03-06
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