针灸胃经腧穴治疗肥胖的2型糖尿病的减重降糖效应研究

注册号:

Registration number:

AMCTR-IOR-20000341 

注册号获得时间:

Date of releasing the registration number:

2020/6/23 10:25:49 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

针灸胃经腧穴治疗肥胖的2型糖尿病的减重降糖效应研究 

Public title:

Clinical Study on the Curative Effect of Acupoints of Stomach Channel on Weight Loss and Hypoglycemic Action in Type 2 Diabetic Patients with Obesity 

研究课题的正式科学名称:

针灸胃经腧穴治疗肥胖的2型糖尿病的减重降糖效应研究 

Scientific title:

Clinical Study on the Curative Effect of Acupoints of Stomach Channel on Weight Loss and Hypoglycemic Action in Type 2 Diabetic Patients with Obesity 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

王翔宇 

研究负责人:

王翔宇 

Applicant:

Wang Xiangyu 

Study leader:

Wang Xiangyu 

申请注册联系人电话:

Applicant telephone:

021-51217552 

研究负责人电话:

Study leader's telephone:

021-51217552 

申请注册联系人传真 :

Applicant Fax:

021-64038038 

研究负责人传真:

Study leader's fax:

021-64038038 

申请注册联系人电子邮件:

Applicant E-mail:

wangxyzsh@126.com 

研究负责人电子邮件:

Study leader's E-mail:

wangxyzsh@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:

上海市徐汇区枫林路180号 

研究负责人通讯地址:

上海市徐汇区枫林路180号 

Applicant address:

No.180, Fenglin Road, Xuhui District, Shanghai 

Study leader's address:

No.180, Fenglin Road, Xuhui District, Shanghai 

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:

复旦大学附属中山医院 

Applicant's institution:

Zhongshan Hospital,Fudan 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:

B2019-310R 

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:

复旦大学附属中山医院医学伦理委员会 

Name of the ethic committee:

Ethics Committee of Zhongshan Hospital, Fudan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-01-13 

研究实施负责(组长)单位:

复旦大学附属中山医院 

Primary sponsor:

Zhongshan Hospital,Fudan University 

研究实施负责(组长)单位地址:

上海市徐汇区枫林路180号 

Primary sponsor's address:

Zhongshan Hospital,Fudan University 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

市(区县):

徐汇

Country:

China

Province:

Shanghai

City:

Xuhui

单位(医院):

复旦大学附属中山医院

具体地址:

上海市徐汇区枫林路180号

Institution
hospital:

Zhongshan Hospital,Fudan University

Address:

Zhongshan Hospital,Fudan University

经费或物资来源:

上海市科学技术委员会 上海市卫生健康委员会 

Source(s) of funding:

Science and Technology Commission of Shanghai Municipality;Shanghai Municipal Health Comission 

研究疾病:

糖尿病 

Target disease:

Diabetes 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional 

研究所处阶段:

其它 

Study phase:

Other 

研究目的:

评价胃经腧穴在肥胖的2型糖尿病中的减重和降糖效果 

Objectives of Study:

This research is to evaluate the efficacy of Acupoints of Stomach Channel on Weight Loss and Hypoglycemic Action in Type 2 Diabetic Patients with Obesity 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

1.年龄18-70岁,性别:无限制 2.体质指数(BMI)大于28,BMI=体重(kg)÷身高^2(m) 3.符合糖尿病诊断标准:空腹血糖大于或等于7.0mmol/L,和/或餐后两小时血糖大于或等于11.1 mmol/L。 4.愿意参加本研究,并签署知情同意书。 

Inclusion criteria

1.Patients aged 18 to 70 years old,gender:unlimited 2.BMI>28, BMI=weight(kg)÷height^2(m) 3.Patients symptoms meet the criteria of diabetes:FBG(fasting blood-glucose) greater than or equal to 7.0mmol/L,and/or 2hPG(2-hour postprandial blood glucose)greater than or equal to 11.1mmol/L. 4.Patients willing to participate in the research and to sign an informed consent. 

排除标准:

1.有其他严重器质性病变,如晚期肿瘤、严重心肺疾病、肾病综合征、精神病及长期使用激素类药物的患者等; 2.妊娠或哺乳期妇女; 3.其他不宜接受针灸治疗者; 4.不愿参加本研究者。 

Exclusion criteria:

1.Patients have severe organic diseases,such as advanced tumor,cardiac, hepatic, renal or mental diseases,and Patients who taked long-term courses of hormone drugs 2.The females who are pregnant or breast-feeding; 3.Patients who is unfit to receive treatment of acupuncture; 4.Patients who refused to participate in the research. 

研究实施时间:

Study execute time:

From2020-07-13To 2022-09-30 

干预措施:

Interventions:

组别:

针刺组

样本量:

60

Group:

Experimental group

Sample size:

干预措施:

针刺

干预措施代码:

Intervention:

Acupuncture

Intervention code:

组别:

浅针刺组

样本量:

60

Group:

Sham Acupuncture

Sample size:

干预措施:

浅针刺

干预措施代码:

Intervention:

Sham Acupuncture

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):

徐汇 

Country:

China 

Province:

Shanghai 

City:

Xuhui 

单位(医院):

复旦大学附属中山医院 

单位级别:

Zhongshan Hospital,Fudan University 

Institution
hospital:

三甲医院  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

体重

指标类型:

主要指标 

Outcome:

Weight

Type:

Primary indicator 

指标中文名:

餐后2小时血糖

指标类型:

次要指标 

Outcome:

2hPG

Type:

Secondary indicator 

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

Pending

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 70 years

随机方法(请说明由何人用什么方法产生随机序列):

区组随机化,随机数字由电脑产生的

性别:

男女均可

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

Block randomization. The computer-generated randomisation schedule used blocks of four.

Gender:

Both

盲法:

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

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):

2023年3月31日,中国针灸临床试验注册中心网站,http://www.acmctr.org/

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

March 31,2023, Chinese Clinical Trial Registry, http://www.acmctr.org/

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

在试验开始之前,所有参与研究的成员均需参加培训,培训内容包括:患者纳入、针刺治疗、病例报告表的填写和数据管理等。在每个时间节点由课题组成员进行随访,并将患者的数据记录在病例报告表中。在专业的统计人员的指导下,由固定的辅助人员进行数据录入并整理成excel文件,并交专业的统计人员进行统计分析。数据监查:本课题组成员定期进行监查。

The repository and management of the data(Please specify what repository will be used for management of the metadata):

Prior to the clinical trial, the staff members are required to participate in the training and its content includes the following: case screening, acupuncture manipulation, CRF record, and data management. The staff members will follow up and fill in the CRF at the evaluation points. The auxiliary staff will enter the data into spreadsheet and verify the content under the guidance of an experienced statistician. Then, these data will be analyzed by statisticians. All the data will be monitored by the staff members.

创建人:

Creater Name:

 2020-06-02
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