今天是:2019-06-17 星期一

减重手术对肥胖患者反应抑制功能缺陷的改善效果及内在神经机制研究
下载XML文档

注册号:

Registration number:

ChiCTR1900021771 

最近更新日期:

Date of Last Refreshed on:

2019-03-10 

注册时间:

Date of Registration:

2019-03-08 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

减重手术对肥胖患者反应抑制功能缺陷的改善效果及内在神经机制研究 

Public title:

Effect of bariatric surgery on the improvement of reaction inhibition function defects in obese patients and its intrinsic neural mechanism 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

减重手术对肥胖患者反应抑制功能缺陷的改善效果及内在神经机制研究 

Scientific title:

Effect of bariatric surgery on the improvement of reaction inhibition function defects in obese patients and its intrinsic neural mechanism 

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:

屠印芳 

研究负责人:

于浩泳 

Applicant:

Yinfang Tu 

Study leader:

Haoyong Yu 

申请注册联系人电话:

Applicant telephone:

+86 18930173809 

研究负责人电话:

Study leader's telephone:

+86 18930173807 

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:

yinfangtian@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

13917766185@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:

上海市宜山路600号上海市第六人民医院内分泌代谢科 

研究负责人通讯地址:

上海市宜山路600号上海市第六人民医院内分泌代谢科 

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:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

上海市第六人民医院 

Applicant's institution:

Department of Endocrinology and Metabolism, Shanghai Sixth People's 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:

2019-KY-011(K) 

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:

上海市第六人民医院伦理委员会 

Name of the ethic committee:

Ethics committee of Shanghai Sixth People's Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-02-18 

伦理委员会联系人:

龚轶钰 

Contact Name of the ethic committee:

Yiyu Gong 

伦理委员会联系地址:

上海市宜山路600号上海市第六人民医院伦理办公室 

Contact Address of the ethic committee:

Ethics Office of Shanghai Sixth People's Hospital, 600 Yishan Road, Shanghai, 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:

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:

上海市宜山路600号上海市第六人民医院 

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:

国家:

中国

省(直辖市):

上海市

市(区县):

徐汇区

Country:

China

Province:

Shanghai

City:

Xuhui District

单位(医院):

上海市第六人民医院

具体地址:

上海市宜山路600号

Institution
hospital:

Shanghai Sixth People's Hospital

Address:

600 Yishan Road, Shanghai

经费或物资来源:

上海市临床重点专科建设项目 

Source(s) of funding:

Shanghai Construction Project of Clinical Key Specialist 

研究疾病:

肥胖症 2型糖尿病 

Target disease:

Obesity, Type 2 diabetes 

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:

通过对肥胖症患者在减重手术前后的行为学结果和ERP成分分析,研究肥胖减重手术对于摄食行为的影响,及其与神经机制变化的关系。 

Objectives of Study:

The effects of bariatric surgery on feeding behavior and its relationship with neurological changes were studied,through the behavioral results and ERP components analysis of obesity patients before and after weight loss surgery. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

①签署知情同意书(ICD)时年满 18 至 65 周岁(含 18 和 65 岁); ②肥胖组体重指数(BMI)超过 28kg/m2(含28kg/m2); 对照组体重指数(BMI)为低于 18.5kg/m2至24kg/m2(含18.5kg/m2和不含24kg/m2); ③受教育程度:初中及以上; ④愿意和能够遵守方案规定的研究流程; ⑤能够理解并签署研究知情同意书。  

Inclusion criteria

1. When the Informed Consent (ICD) is signed, it is 18 to 6