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2型糖尿病肾病患者循环Sestrin2水平的研究
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注册号:

Registration number:

ChiCTR1800019561 

最近更新日期:

Date of Last Refreshed on:

2018-11-18 

注册时间:

Date of Registration:

2018-11-18 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

2型糖尿病肾病患者循环Sestrin2水平的研究 

Public title:

Study for the level of Circulating Sestrin2 in patients with type 2 diabetes and nephropathy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

2型糖尿病肾病患者循环Sestrin2水平的研究 

Scientific title:

Study for the level of Circulating Sestrin2 in patients with type 2 diabetes and nephropathy 

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:

孙晓东 

研究负责人:

孙晓东 

Applicant:

Sun Xiaodong 

Study leader:

Sun Xiaodong 

申请注册联系人电话:

Applicant telephone:

+86 18653625906 

研究负责人电话:

Study leader's telephone:

+86 18653625906 

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:

xiaodong.sun@wfmc.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

xiaodong.sun@wfmc.edu.cn 

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:

山东省潍坊市奎文区虞河路2428号 

研究负责人通讯地址:

山东省潍坊市奎文区虞河路2428号 

Applicant address:

2428 Yuhe Road, Weifang, Shandong, China 

Study leader's address:

2428 Yuhe Road, Weifang, Shandong, China 

申请注册联系人邮政编码:

Applicant postcode:

261031 

研究负责人邮政编码:

Study leader's postcode:

261031 

申请人所在单位:

潍坊医学院附属医院 

Applicant's institution:

Affiliated Hospital of Weifang Medical 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:

2018-8 

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:

潍坊医学院附属医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Weifang Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-11-15 

伦理委员会联系人:

周政敏 

Contact Name of the ethic committee:

Zhengmin Zhou 

伦理委员会联系地址:

潍坊市虞河路2428号 

Contact Address of the ethic committee:

2428 Yuhe Road, Weifang, Shandong, China 

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:

潍坊医学院附属医院 

Primary sponsor:

Affiliated Hospital of Weifang Medical University 

研究实施负责(组长)单位地址:

山东省潍坊市奎文区虞河路2428号 

Primary sponsor's address:

2428 Yuhe Road, Weifang, Shandong, 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):

山东省潍坊市

市(区县):

奎文区

Country:

China

Province:

Shandong

City:

单位(医院):

潍坊医学院附属医院

具体地址:

山东省潍坊市奎文区虞河路465号

Institution
hospital:

Affiliated Hospital of Weifang Medical University

Address:

465 Yuhe Road, Kuiwen District, Weifang, Shandong, China

经费或物资来源:

国家自然科学基金 

Source(s) of funding:

National Natural Science Foundation of China  

研究疾病:

糖尿病 

Target disease:

diabetes 

研究疾病代码:

 

Target disease code:

 

研究类型:

病因学/相关因素研究 

Study type:

Cause/Relative factors study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

研究观察2型糖尿病肾病循环Sestrin2的水平。 

Objectives of Study:

Study on the level of Circulating Sestrin2 in patients with type 2 diabetes and nephropathy 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

病例对照研究 

Study design:

Case-Control study 

纳入标准:

①2型糖尿病合并肾病(I-V期)②年龄在18-75岁 ③理解试验目的,并自愿签署知情同意书 

Inclusion criteria

1. Type 2 diabetes with nephropathy; 2. Aged 18-75 years old; 3. Understand the purpose of clinical trials and voluntarily participate in and sign informed consent.  

排除标准:

①糖尿病急性并发症(包括糖尿病酮症酸中毒、糖尿病高渗状态);②肝功能受损、心功能不全等;③急性感染、肿瘤、妊娠。 

Exclusion criteria:

1. acute complications of diabetes (including diabetic ketoacidosis, diabetic hyperosmolar state); 2. liver function impairment, cardiac insufficiency, etc.; 3. acute infection, tumor, pregnancy. 

研究实施时间:

Study execute time:

From2018-11-26To 2020-11-30 

干预措施:

Interventions:

组别:

2型糖尿病肾病I期

样本量:

30

Group:

Type 2 diabetic nephropathy stage I

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Intervention code:

组别:

2型糖尿病肾病II期

样本量:

30

Group:

type 2 diabetic nephropathy stage II

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Intervention code:

组别:

2型糖尿病肾病III期

样本量:

30

Group:

type 2 diabetic nephropathy stage III

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Intervention code:

组别:

2型糖尿病肾病IV期

样本量:

30

Group:

type 2 diabetic nephropathy stage IV

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Intervention code:

组别:

2型糖尿病肾病V期

样本量:

30

Group:

type 2 diabetic nephropathy stage V

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Intervention code:

组别:

新发2型糖尿病组

样本量:

30

Group:

new type 2 diabetes group

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Intervention code:

组别:

normal control group

样本量:

30

Group:

正常对照组

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

山东省 

省(直辖市):

潍坊市 

市(区县):

奎文区 

Country:

China 

Province:

Shandong 

City:

 

单位(医院):

潍坊医学院附属医院 

单位级别:

三级甲等 

Institution
hospital:

Affiliated Hospital of Weifang Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

Sestrin2

指标类型:

主要指标 

Outcome:

Sestrin2

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

糖化血红蛋白

指标类型:

次要指标 

Outcome:

HbA1c

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体质指数

指标类型:

次要指标 

Outcome:

BMI

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血压

指标类型:

次要指标 

Outcome:

BP

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿白蛋白/肌酐比

指标类型:

次要指标 

Outcome:

Urinary albumin/creatinine ratio

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肾小球滤过率

指标类型:

次要指标 

Outcome:

GFR

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 75 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):

N/A

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

N/A

盲法:

N/A

Blinding:

N/A

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

中国临床试验注册中心

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

China Clinical Trial Registry

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:

采集到的病人的信息和实验数据将通过纸质文档或者电子文档保存,每个病人均有一个以受试时间排列的编号,在需要查找病人信息时可以通过病人的编号搜索,此外,病人的名字将不被记录。

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

We will record patients's infromation and experiment data acording to papers or saved as eclectrical files in computer. Each patient possesses a number which comes from the experiment date and the numbers arranged follow the chronological order. In addition, patients' name will not be recorded.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-11-18
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