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A study for the interaction between NAFLD based on the genetic and atherosclerosis and the individual treatment scheme of fatty liver (Key Project)
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注册号:

Registration number:

ChiCTR-ROC-15006447 

最近更新日期:

Date of Last Refreshed on:

2015-05-27 

注册时间:

Date of Registration:

2015-05-24 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

基于遗传学的NAFLD和动脉粥样硬化相互作用及脂肪肝个体化诊疗方案研究(重点项目) 

Public title:

A study for the interaction between NAFLD based on the genetic and atherosclerosis and the individual treatment scheme of fatty liver (Key Project) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于遗传学的NAFLD和动脉粥样硬化相互作用及脂肪肝个体化诊疗方案研究(重点项目) 

Scientific title:

A study for the interaction between NAFLD based on the genetic and atherosclerosis and the individual treatment scheme of fatty liver (Key Project) 

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:

辛永宁 

研究负责人:

宣世英 

Applicant:

Yongning Xin 

Study leader:

Shiying Xuan 

申请注册联系人电话:

Applicant telephone:

+86 13105121889 

研究负责人电话:

Study leader's telephone:

+86 0532-88905508 

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:

xinyongning@163.com 

研究负责人电子邮件:

Study leader's E-mail:

dxyxyn@163.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:

青岛市胶州路1号 

研究负责人通讯地址:

青岛市胶州路1号 

Applicant address:

1 Jiaozhou Road, Qingdao, China 

Study leader's address:

1 Jiaozhou Road, Qingdao, 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:

青岛市市立医院消化内二科 

Applicant's institution:

Department of Gastroenterology-II, Qingdao Municipal Hospital 

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:

(2015年度)伦审研第(01)号 

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:

青岛市市立医院伦理委员会 

Name of the ethic committee:

ethics committee of Qingdao Municipal Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

 

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:

青岛市市立医院 

Primary sponsor:

Qingdao Municipal Hospital 

研究实施负责(组长)单位地址:

青岛市胶州路1号 

Primary sponsor's address:

1 Jiaozhou Road, Qingdao, 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

市(区县):

青岛

Country:

China

Province:

Shandong

City:

Qingdao

单位(医院):

青岛市市立医院

具体地址:

青岛市胶州路1号

Institution
hospital:

Qingdao Municipal Hospital

Address:

1 Jiaozhou Road, Qingdao, China

经费或物资来源:

青岛市科技局 

Source(s) of funding:

supported by Qingdao Science and Technology Project, China 

研究疾病:

非酒精性脂肪性肝病和动脉粥样硬化 

Target disease:

NAFLD and AS 

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:

其它 

Study phase:

N/A 

研究目的:

从遗传学角度探索NAFLD与AS关系及与NAFLD 密切相关基因与AS的关系,筛选NAFLD合并AS早期诊断的分子标 志物及治疗靶点,制定临床个体化诊疗方案,为NAFLD最终防治提供可靠的循证医学证据。 

Objectives of Study:

From the perspective of genetics,we were to explore the relationship between NAFLD and AS ,as well as the relationship between gene closely associated with NAFLD and AS, to screen out the early diagnosis molecular markers and therapeutic targets of NAFLD combined with AS, developing a clinical individualized diagnosis and treatment plan, and eventually provide a reliable evidence of evidence-based medicine for prevention and control of NAFLD. 

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:

标准参照《非酒精性脂肪性肝病诊疗指南(2010年修订版)》 

Inclusion criteria

Standard refers to "diagnosis and treatment guidelines of nonalcoholic fatty liver disease (2010 revision)" 

排除标准:

排除乙型和丙型等病毒性肝炎、药物性肝病、肝豆状核变性、自身免疫性肝病等其他可导致脂肪肝的疾病,且每周饮酒>140g者除外。 

Exclusion criteria:

Exclusion criteria were individual with Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection, drug-induced liver disease, liver degeneration, autoimmune liver disease, a history of alcohol consumption (>140 g/week in male or 70 g/week in female). 

研究实施时间:

Study execute time:

From2014-09-01To 2016-09-01 

干预措施:

Interventions:

组别:

All population

样本量:

3900

Group:

All population

Sample size:

干预措施:

多烯磷脂酰胆碱胶囊(易善复)

干预措施代码:

Intervention:

Polyene Phosphatidylcholine Capsules (Yi Shanfu)

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

山东 

市(区县):

青岛 

Country:

China 

Province:

Shandong 

City:

Qingdao 

单位(医院):

青岛市市立医院 

单位级别:

三级甲等 

Institution
hospital:

Qingdao Municipal Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

基因多态性

指标类型:

主要指标 

Outcome:

genetic polymorphism

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:

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 24 years
最大 Max age 70 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):

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

NO

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):

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:

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2015-05-24
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