今天是:2020-08-11 星期二

中国1型糖尿病纵向队列建立项目
下载XML文档

注册号:

Registration number:

ChiCTR2000034642 

最近更新日期:

Date of Last Refreshed on:

2020-07-13 

注册时间:

Date of Registration:

2020-07-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中国1型糖尿病纵向队列建立项目 

Public title:

Project to establish a longitudinal cohort of Type 1 diabetes in China 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中国1型糖尿病纵向队列建立项目 

Scientific title:

Project to establish a longitudinal cohort of Type 1 diabetes in China 

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:

郑雪瑛 

研究负责人:

翁建平、严晋华 

Applicant:

Xueying Zheng 

Study leader:

Jianping Weng, Jinhua Yan 

申请注册联系人电话:

Applicant telephone:

+86 18520126722 

研究负责人电话:

Study leader's telephone:

+86 13903000303 

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:

lisazhengxy@163.com 

研究负责人电子邮件:

Study leader's E-mail:

wengjp@vip.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:

中国安徽省合肥市庐江路17号 

研究负责人通讯地址:

中国安徽省合肥市庐江路17号 

Applicant address:

17 Lujiang Road, Hefei, Anhui, China 

Study leader's address:

17 Lujiang Road, Hefei, Anhui, 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:

中国科学技术大学附属第一医院 

Applicant's institution:

The First Affiliated Hospital of USTC 

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:

中大附三医伦[2014]2-105(补)1号 

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:

中山大学附属第三医院临床医学研究伦理委员会 

Name of the ethic committee:

The Ethics Committee of the Third Affiliated Hospital of Sun Yat-Sen University 

伦理委员会批准日期:

Date of approved by ethic committee:

2015-07-27 

伦理委员会联系人:

吴斌 

Contact Name of the ethic committee:

Wu Bin 

伦理委员会联系地址:

广州市天河区天河路600号 

Contact Address of the ethic committee:

600 Tianhe Road, Tianhe 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:

中山大学附属第三医院 

Primary sponsor:

The Third Affliated Hospital of Sun Yat-Sen Univeristy 

研究实施负责(组长)单位地址:

广州市天河区天河路600号 

Primary sponsor's address:

600 Tianhe Road, Tianhe 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国医师协会

具体地址:

丰台区广安路9号国投财富广场5号楼

Institution
hospital:

Chinese Medical Doctor Association

Address:

Seat 5, Guotou Fortune Plaza, 9 Guang'an Road, Fengtai Distric, Beijing

经费或物资来源:

中华国际医学交流基金会 

Source(s) of funding:

China International Medical Foundation 

研究疾病:

1型糖尿病 

Target disease:

Type 1 Diabetes 

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:

建立国内最大样本量的1型糖尿病队列,帮助邀请医院跟踪随访患者,通过对这些患者的登记和追踪随访,进一步揭示我国1型糖尿病患者的临床特征及存在的管理问题。 

Objectives of Study:

The aim of the Program is to establish the largest sample size of type 1 diabetes cohort in China, and investigate demographic and clinical characteristics of Chinese patients with T1D and to assess metabolic control, the control of other risk factors and diabetic complications, improve the quality of life and decrease the mortality rate of these patients.  

药物成份或治疗方案详述:

本项目通过建立一个功能齐全的糖尿病登记网络平台,制定1型糖尿病病例登记报告制度,将中国1型糖尿病患者资料登记在案并纳入统一管理。随访期间,定期登记患者的个人资料、起病情况,同时进行体格检查以及生物指标的检测。  

Description for medicine or protocol of treatment in detail:

The network database system is established in China. T1D patients who visited the participating hospitals would be registered in the system and educated at each visiting. Clinical data, information on demographics and medical history would be collected prospectively at enrollment and visiting once a year thereafter. Meanwhile, anthropometric measurements and biological testing will be performed.  

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

(1)由内分泌专科医师临床诊断的T1DM患者至少符合以下4项条件中的一条: ①糖尿病代谢紊乱症状(多饮、多尿、多食或体重减轻)明显; ②发生过糖尿病酮症或酮症酸中毒(DKA); ③胰岛相关自身抗体如谷氨酸脱梭酶抗体(GAD65)、胰岛细胞抗体(ICA)或酪氨酸磷酸酶抗体(IA-2/IA-2 B)等检测阳性; ④空腹C肤和刺激后C肽≤200 pmo/L; (2)每天均需胰岛素治疗。 

Inclusion criteria

1. Participants diagnosed with T1DM by endocrinologists and met at least one of the following conditions (1) Obvious diabetes-related metabolic disorder symptoms; (2) Previous diabetic ketosis or ketoacidosis; (3) Tested positive for diabetes autoantibodies such as GAD65, ICA, IA-2/IA-2 beta; (4) Had fasting C-peptide level less than 200 pmol/l and stimulated C-peptide less than 500pmol/l; 2. Insulin treatment every day. 

排除标准:

(1)其他类型糖尿病; (2)其他严重伴随疾病(预期寿命<1年)。 

Exclusion criteria:

1. Other special types of diabetes; 2. Life expectancy less than one year, such as advanced cancer and serious diseases, assessed by researchers. 

研究实施时间:

Study execute time:

From2018-05-01To 2021-04-30 

征募观察对象时间:

Recruiting time:

From2020-08-01To 2021-04-30 

干预措施:

Interventions:

组别:

Case series

样本量:

3000

Group:

Case series

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):

广东省 

市(区县):

广州市 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

中山大学附属第三医院 

单位级别:

三甲医院 

Institution
hospital:

The Third Affiliated Hospital of Sun Yat-Sen University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

安徽省 

市(区县):

合肥市 

Country:

China 

Province:

Anhui 

City:

Hefei 

单位(医院):

中国科学技术大学附属第一医院 

单位级别:

三甲医院 

Institution
hospital:

The First Affiliated Hospital of USTC  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

糖化血红蛋白

指标类型:

主要指标 

Outcome:

HbA1c

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

空腹血糖

指标类型:

次要指标 

Outcome:

fasting blood glucose

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

随机血糖

指标类型:

次要指标 

Outcome:

random glucose

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

C肽

指标类型:

次要指标 

Outcome:

c-peptide

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血压

指标类型:

次要指标 

Outcome:

blood pressure

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血脂

指标类型:

次要指标 

Outcome:

lipid

Type:

Secondary 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:

次要指标 

Outcome:

BMI

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿蛋白排泄率

指标类型:

次要指标 

Outcome:

ACR

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

菌群多样性

指标类型:

次要指标 

Outcome:

feces

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:

血液

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

标本中文名:

尿液

组织:

Sample Name:

Urea

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

粪便

组织:

Sample Name:

feces

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

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 0 years
最大 Max age 99 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):

No

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):

暂未确定; ResMan

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

NA; 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:

本项目有纸质版病例记录表(CRF)表格,供研究者登记和随访时记录患者临床资料;本项目也设计了网络数据库,供研究者将CRF表格内容填写到网络数据库

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

Case report form(CRF) will be performed for researchers to record the clinical information when registering. A network database is also provided for uploading and saving information data.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-07-12
返回列表