今天是:2019-11-21 星期四

禁食疗法改善超重/肥胖患者血管功能的作用及机制研究
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注册号:

Registration number:

ChiCTR1900024290 

最近更新日期:

Date of Last Refreshed on:

2019-07-05 

注册时间:

Date of Registration:

2019-07-05 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

禁食疗法改善超重/肥胖患者血管功能的作用及机制研究 

Public title:

Effect and Underlying Mechanism of Fasting Therapy on Vascular Function in Overweight/Obesity  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

禁食疗法改善超重/肥胖患者血管功能的作用及机制研究 

Scientific title:

Effect and Underlying Mechanism of Fasting Therapy on Vascular Function in Overweight/Obesity  

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:

孙佳盼 

研究负责人:

陶军 

Applicant:

Jiapan Sun 

Study leader:

Jun Tao 

申请注册联系人电话:

Applicant telephone:

+86 15622122042 

研究负责人电话:

Study leader's telephone:

+86 13922191609 

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:

sunjp3@mail2.sysu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

taojungz123@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:

广东省广州市越秀区中山二路58号 

研究负责人通讯地址:

广东省广州市越秀区中山二路58号 

Applicant address:

58 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, China 

Study leader's address:

58 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, 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:

中山大学附属第一医院 

Applicant's institution:

The First Affiliated Hospital of Sun Yat-sen 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:

[2019]085 

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:

中山大学附属第一医院临床科研和实验动物伦理委员会 

Name of the ethic committee:

ICE for Clinical Research and Animal Trials of the First Affiliated Hospital of Sun Yat-sen University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-01-30 

伦理委员会联系人:

颜楚荣 

Contact Name of the ethic committee:

Churong Yan 

伦理委员会联系地址:

广东省广州市越秀区中山二路58号 

Contact Address of the ethic committee:

58 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, 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:

中山大学附属第一医院 

Primary sponsor:

The First Affiliated Hospital of Sun Yat-sen University 

研究实施负责(组长)单位地址:

广东省广州市越秀区中山二路58号 

Primary sponsor's address:

58 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, 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):

广东

市(区县):

Country:

China

Province:

Guangdong

City:

单位(医院):

中山大学附属第一医院

具体地址:

广东省广州市越秀区中山二路58号

Institution
hospital:

The First Affiliated Hospital of Sun Yat-sen University

Address:

58 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, China

经费或物资来源:

中国国家自然科学基金 

Source(s) of funding:

National Natural Science Foundation of China 

研究疾病:

超重和肥胖 

Target disease:

overweight/obesith 

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:

验证禁食疗法对血管内皮功能保护的作用,为血管保护提供新的思路方案和理论依据。 

Objectives of Study:

To verify the protective effect of fasting therapy on vascular endothelial function, and provide new ideas and theoretical basis for vascular endothelial function protection. 

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 25-65岁,性别不限; (2)BMI ≥ 25kg/m2; (3)入选前均已告知研究具体内容及其中涉及自身利害的事项,并签署知情同意书。  

Inclusion criteria

(1) High BMI persons (BMI>=25kg/m2); (2) Aged between 25 to 65 years; (3) Signed the informed consent.  

排除标准:

(1)妊娠期、哺乳期或月经期女性; (2)心、肝、肾功能异常者; (3)二级以上高血压患者; (4)注射胰岛素的 2 型糖尿病患者; (5)严重胃出血的溃疡患者; (6)恶性肿瘤及血液病患者; (7)活动性肺结核患者; 

Exclusion criteria:

(1) People with abnormal heart, liver or kidney function; (2) Hypertension above the second grade; (3) Insulin using; (4) Severe gastric bleeding, cancers, blood diseases, active tuberculosis; (5) women during pregnancy, lactation or menstruation.  

研究实施时间:

Study execute time:

From2017-03-20To 2019-05-30 

干预措施:

Interventions:

组别:

高体重指数组

样本量:

13

Group:

Case series

Sample size:

干预措施:

7天禁食疗法加左旋肉碱

干预措施代码:

Intervention:

Seven-day fasting therapy with L-carnitine

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

中山大学附属第一医院 

单位级别:

三甲 

Institution
hospital:

The First Affiliated Hospital of Sun Yat-sen University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

肱动脉血流介导性舒张功能

指标类型:

主要指标 

Outcome:

flow-mediated vasodilatation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肱桡动脉脉搏波传导速度

指标类型:

主要指标 

Outcome:

brachial-ankle pulse wave velocity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

反应性充血指数

指标类型:

次要指标 

Outcome:

reactive hyperemia index

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:

静脉血

组织:

Sample Name:

venous 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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 25 years
最大 Max age 65 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):

未使用随机分组方法。

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

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

ResMan

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

ResMan

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:

未说明

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

Not stated

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2019-07-05
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