脂肪及肌肉因子在血压调控中的作用及与原发性高血压发病关系的研究

注册号:

Registration number:

ChiCTR1800016761 

最近更新日期:

Date of Last Refreshed on:

2023-04-03 11:15:30 

注册时间:

Date of Registration:

2018-06-22 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

脂肪及肌肉因子在血压调控中的作用及与原发性高血压发病关系的研究

Public title:

The regulation of adipokines and myokines on blood pressure and the role in pathogenesis of hypertension

注册题目简写:

English Acronym:

研究课题的正式科学名称:

脂肪及肌肉因子在血压调控中的作用及与原发性高血压发病关系的研究

Scientific title:

The regulation of adipokines and myokines on blood pressure and the role in pathogenesis of hypertension

研究课题代号(代码):

Study subject ID:

国家自然科学基金(No. 81770299; 81700371)

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:

陈垦 

研究负责人:

杨大春 

Applicant:

Ken Chen 

Study leader:

Dachun Yang 

申请注册联系人电话:

Applicant telephone:

+86 13594081709

研究负责人电话:

Study leader's
telephone:

+86 18608003481

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:

ck_tmmu@sina.com

研究负责人电子邮件:

Study leader's E-mail:

yangdc71@126.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:

四川省成都市金牛区蓉都大道270号

研究负责人通讯地址:

四川省成都市金牛区蓉都大道270号

Applicant address:

270 Rongdu Avenue, Jinniu District, Chengdu, Sichuan, China

Study leader's address:

270 Rongdu Avenue, Jinniu District, Chengdu, Sichuan, 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:

成都军区总医院

Applicant's institution:

Chengdu Military General Hospital

研究负责人所在单位:

成都军区总医院

Affiliation of the Leader:

Chengdu Military General Hospital

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

2018ky07

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:

成都军区总医院伦理委员会

Name of the ethic committee:

the Ethics Committee of Chengdu Military General Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

1990-01-01 00:00:00

伦理委员会联系人:

王攀

Contact Name of the ethic committee:

Pan Wang

伦理委员会联系地址:

四川省成都市金牛区蓉都大道270号

Contact Address of the ethic committee:

270 Rongdu Avenue, Jinniu District, Chengdu, Sichuan, 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:

成都军区总医院

Primary sponsor:

Chengdu Military General Hospital

研究实施负责(组长)单位地址:

四川省成都市金牛区蓉都大道270号

Primary sponsor's address:

270 Rongdu Avenue, Jinniu District, Chengdu, Sichuan, 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):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

成都军区总医院

具体地址:

四川省成都市金牛区蓉都大道270号

Institution
hospital:

Chengdu Military General Hospital

Address:

270 Rongdu Avenue, Jinniu District

经费或物资来源:

国家自然科学基金(No. 81770299; 81700371)

Source(s) of funding:

National Natural Science Foundation of China (No. 81770299; 81700371)

研究疾病:

高血压  

Target disease:

Hypertension

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:

回顾性研究 

Study phase:

Retrospective study

研究设计:

病例对照研究 

Study design:

Case-Control study 

研究目的:

探索循环脂肪因子及肌肉因子对血压的调控作用及其与高血压发病的关系。  

Objectives of Study:

To identify the correlation between adipokines/myokines levels and blood pressure and the role of adipokines/myokines in hypertension

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

① 继发性高血压;② 急性心肌梗死和脑卒中急性期(<3个月);③ 不易配合(智力听力肢体活动明显障碍);④ 合并严重疾病预期寿命不足1年;⑤ 个人不愿加入本项目。

Exclusion criteria:

1. secondary hypertension;
2. acute myocardial infarction and acute stroke (less than 3 months);
3. Mental and physical disability;
4. Combined severe disease, life expectancy is less than 1 year;
5. refusing to join the project.

研究实施时间:

Study execute time:

From 2018-04-01 00:00:00 To 2019-04-01 00:00:00  

征募观察对象时间:

Recruiting time:

From 2018-04-01 00:00:00 To 2018-10-31 00:00:00

干预措施:

Interventions:

组别:

对照组

样本量:

200

Group:

Control

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

组别:

高血压组

样本量:

200

Group:

Hypertension group

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

四川 

市(区县):

成都 

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

成都军区总医院 

单位级别:

三甲 

Institution
hospital:

Chengdu Military General Hospital

Level of the institution:

Tertiary A hospital

测量指标:

Outcomes:

指标中文名:

血压

指标类型:

主要指标

Outcome:

blood pressure

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

踝臂指数

指标类型:

主要指标

Outcome:

ABI

Type:

Primary 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:

主要指标

Outcome:

BMI

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

饮食

指标类型:

次要指标

Outcome:

diet

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

吸烟

指标类型:

次要指标

Outcome:

smoking

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血糖

指标类型:

主要指标

Outcome:

blood pressure

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血脂

指标类型:

主要指标

Outcome:

blood lipids

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肾脏功能

指标类型:

主要指标

Outcome:

renal function

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 years
最大 Max age 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):

由周梦迪和王晓梅采用随机数表对对照组进行随机抽样,并保证年龄、姓名与高血压组符合

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

The controls were sampled according a random number table, and age/gender matched.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

是Yes

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):

原始数据公开,可通过邮件等方式向研究负责人索取

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

The orignal data can be provided from the principal investigator via mail.

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:

数据采集和管理采用病例记录表。

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

Case Record Form (CRF) is used for data collection and management.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2018-06-22 11:22:52