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Imbalance of Th22/Treg cells causes microinflammation in uremic patients undergoing hemodialysis
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注册号:

Registration number:

ChiCTR1900024609 

最近更新日期:

Date of Last Refreshed on:

2019-07-18 

注册时间:

Date of Registration:

2019-07-18 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

Th22/Treg细胞及相关细胞因子在尿毒症血液透析患者微炎症中的作用研究 

Public title:

Imbalance of Th22/Treg cells causes microinflammation in uremic patients undergoing hemodialysis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

Th22/Treg细胞及相关细胞因子在尿毒症血液透析患者微炎症中的作用研究 

Scientific title:

Imbalance of Th22/Treg cells causes microinflammation in uremic patients undergoing hemodialysis 

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:

任婷婷 

研究负责人:

任婷婷 

Applicant:

Tingting Ren 

Study leader:

Tingting Ren 

申请注册联系人电话:

Applicant telephone:

+86 18328718525 

研究负责人电话:

Study leader's telephone:

+86 18328718525 

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:

r_rentingting@163.com 

研究负责人电子邮件:

Study leader's E-mail:

r_rentingting@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:

四川成都市清水滨河路788号 

研究负责人通讯地址:

四川成都市清水滨河路788号 

Applicant address:

788 Qingshui Binhe Road, Chengdu, Sichuan, China 

Study leader's address:

788 Qingshui Binhe Road, Chengdu, Sichuan, China 

申请注册联系人邮政编码:

Applicant postcode:

610000 

研究负责人邮政编码:

Study leader's postcode:

610000 

申请人所在单位:

成都市第十一人民医院肾内科 

Applicant's institution:

Department of Nephrology, the Eleventh People's Hospital of Chengdu 

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:

201401003 

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:

成都市第十一人民医院伦理委员会 

Name of the ethic committee:

The Ethic Commitee of the Eleventh People's Hospital of Chengdu 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-01-16 

伦理委员会联系人:

李超 

Contact Name of the ethic committee:

Chao Li 

伦理委员会联系地址:

四川成都市清水滨河路788号 

Contact Address of the ethic committee:

788 Qingshui Binhe Road, 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:

成都市第十一人民医院肾内科 

Primary sponsor:

Department of Nephrology, the Eleventh People's Hospital of Chengdu 

研究实施负责(组长)单位地址:

四川成都市清水滨河路788号 

Primary sponsor's address:

788 Qingshui Binhe Road, 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):

成都市第十一人民医院

具体地址:

四川成都市清水滨河路788号

Institution
hospital:

the Eleventh People’s Hospital of Chengdu

Address:

788 Qingshui Binhe Road

经费或物资来源:

院内项目 

Source(s) of funding:

Hospital funds 

研究疾病:

尿毒症 

Target disease:

Uremia 

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:

探讨Th22/Treg细胞及相关细胞因子在尿毒症血液透析患者微炎症中的作用 

Objectives of Study:

Regulatory T (Treg) cells play an important role in immune activation and inflammation in HD patients. We examined association between Th22/Treg cell imbalance and microinflammation in uremic patients undergoing HD. 

药物成份或治疗方案详述:

收集我院尿毒症患者146例,其中行血液透析治疗患者82例为透析组,未行血液透析治疗患者64例为非透析组,同时选取在本院门诊做健康体检的志愿者42例作为对照组。纳入的研究者均抽取外周静脉血,分离外周血单个核细胞,流式细胞术测定三组外周血中Th22、Treg细胞频数,采用酶联免疫吸附法测定血清中相关细胞因子IL-22、IL-10和炎症因子CRP、TNF-?、IL-6的水平。同时观察透析3月组、12月组、24月组患者的微炎症(CRP)及透析充分性(iPTH、Kt/V、?2-MG、血磷、血钙),并分析透析充分性与微炎症的相关性。 

Description for medicine or protocol of treatment in detail:

Peripheral blood mononuclear cells (PBMCs) were isolated to measure percentages of Th22 and Treg cells. Serum levels of related cytokines IL-22 and IL-10 and inflammatory factors CRP, TNF-α and IL-6 were determined as well as their correlation with Th22/Treg cells. Relationships among dialysis time, microinflammation status (CRP) and dialysis adequacy (iPTH, Kt/V, β2-MG, serum calcium and serum phosphorus) were also evaluated. Finally, relationship between microinflammation status and dialysis adequacy was measured with correlation analysis. 

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:

尿毒症血液透析患者 

Inclusion criteria

uremic patients undergoing HD 

排除标准:

(1)近三个月有手术史、外伤史; (2)有缺血性心脏病、脑血管病、血液病、肝炎、恶性重量、艾滋、精神疾病等; (3)资料不全者; (4)近两周内急性感染; (5)近6个月内使用过激素和免疫抑制剂; (6)近一个月内使用过他汀类药物、左旋卡尼汀、噻唑烷二酮类降糖药。 

Exclusion criteria:

(1) a history of surgery and trauma in the past three months; (2) presence of ischemic heart disease, cerebrovascular disease, blood disease, hepatitis, malignant weight, AIDS, and mental illness, or other similar conditions; (3) incomplete research data; (4) With acute infection in the past two weeks; (5) used hormones and immunosuppressants in the past six months; (6) used statins, levocarnitine and thiazolidinedione hypoglycemic agents in the past month. 

研究实施时间:

Study execute time:

From2014-02-01To 2016-02-24 

干预措施:

Interventions:

组别:

透析组

样本量:

82

Group:

dialysis group

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

组别:

非透析组

样本量:

64

Group:

non-dialysis group

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

组别:

健康人群对照组

样本量:

42

Group:

Health people control group

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

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):

成都市第十一人民医院 

单位级别:

三甲 

Institution
hospital:

the Eleventh People’s Hospital of Chengdu  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

IL-22

指标类型:

主要指标 

Outcome:

IL-22

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

IL-10

指标类型:

主要指标 

Outcome:

IL-10

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CRP

指标类型:

主要指标 

Outcome:

CRP

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

TNF-alpha

指标类型:

主要指标 

Outcome:

TNF-alpha

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

IL-6

指标类型:

主要指标 

Outcome:

IL-6

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 36 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):

N/A

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):

点击下载

Calculated Results ater
the Study Completed(upload file):

download

原始数据公开时间:

The time of sharing IPD:

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):

试验结束后上传原始数据到本网站

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

the original data will be Upload to this web site after the trial

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:

试验记录

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

record

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-07-18
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