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The role of NOS1AP and its signaling pathway regulation in the development of diabetes
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注册号:

Registration number:

ChiCTR1800016376 

最近更新日期:

Date of Last Refreshed on:

2018-05-28 

注册时间:

Date of Registration:

2018-05-28 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

NOS1AP及其信号通路与糖尿病发生发展的关联研究 

Public title:

The role of NOS1AP and its signaling pathway regulation in the development of diabetes 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

NOS1AP及其信号通路与糖尿病发生发展的关联研究 

Scientific title:

The role of NOS1AP and its signaling pathway regulation in the development of diabetes 

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:

王琛 

研究负责人:

王琛 

Applicant:

Chen WANG 

Study leader:

Chen WANG 

申请注册联系人电话:

Applicant telephone:

+86 18930177004 

研究负责人电话:

Study leader's telephone:

+86 18930177004 

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:

wangchen@sjtu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

wangchen@sjtu.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:

上海宜山路600号 

研究负责人通讯地址:

上海宜山路600号 

Applicant address:

600 Yishan Road, Shanghai, China 

Study leader's address:

600 Yishan Road, Shanghai, China 

申请注册联系人邮政编码:

Applicant postcode:

200233 

研究负责人邮政编码:

Study leader's postcode:

200233 

申请人所在单位:

上海市第六人民医院 

Applicant's institution:

Shanghai Sixth People's Hospital 

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:

上海市第六人民医院 

Primary sponsor:

Shanghai Sixth People's Hospital 

研究实施负责(组长)单位地址:

上海宜山路600号 

Primary sponsor's address:

600 Yishan Road, Shanghai, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

自筹 

Source(s) of funding:

Self support 

研究疾病:

肥胖、脂肪肝 

Target disease:

Obesity, NAFLD 

研究疾病代码:

 

Target disease code:

 

研究类型:

基础科学研究 

Study type:

Basic science 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

围绕NOS1AP-nNOS在胰岛 β细胞和外周胰岛素靶组织中的作用和作用机制进行研究,以期揭示NOS1AP及其信号通路在糖尿病发生发展中的作用,发现调控β细胞功能和外周胰岛素敏感性的新因子,这将有助于研发基于保护胰岛β 细胞功能/容量和胰岛素敏感性的新型治疗靶点。 

Objectives of Study:

In order to reveal the role of NOS1AP and its signaling pathway in the development of diabetes mellitus, the role and mechanism of nos1ap-nnos in beta cells and peripheral insulin target tissues were studied, which would help develop a new therapeutic target for the regulation of beta-cell function/capacity and peripheral insulin sensitivity.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

①年龄20~79岁;②不患有其他内分泌疾病。 

Inclusion criteria

1. Age:20-79 years old; 2. without other endocrine diseases.  

排除标准:

1型糖尿病患者,妊娠、哺乳妇女。 

Exclusion criteria:

Type 1 diabetes, women in pregency or lactation.  

研究实施时间:

Study execute time:

From2018-05-25To 2018-12-30 

干预措施:

Interventions:

组别:

Case series

样本量:

100

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市第六人民医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Sixth People's Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

NOS1AP/NOS表达

指标类型:

主要指标 

Outcome:

expression of NOS1AP/NOS

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:

组织

组织:

胰腺、肝脏、肌肉和脂肪组织

Sample Name:

Tissue

Tissue:

liver, muscle ,fat, pancreas

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 20 years
最大 Max age 79 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):

样本的采集采用收集时间段中所有符合入选标准的例数。

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

A total of 100 samples med the inclusion criteria was collected.

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:

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):

NA

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

NA

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:

NA

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

NA

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-05-28
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