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降糖药物对2型糖尿病的动脉粥样硬化的改善作用
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注册号:

Registration number:

ChiCTR-ORC-17010835 

最近更新日期:

Date of Last Refreshed on:

2017-03-10 

注册时间:

Date of Registration:

2017-03-10 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

降糖药物对2型糖尿病的动脉粥样硬化的改善作用 

Public title:

Comparison of anti-diabetic medications during the treatment of atherosclerosis in T2DM patients 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

降糖药物对2型糖尿病的动脉粥样硬化的改善作用 

Scientific title:

Comparison of anti-diabetic medications during the treatment of atherosclerosis in T2DM patients 

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:

刘晓洁 

研究负责人:

叶山东 

Applicant:

Xiaojie Liu 

Study leader:

Shandong Ye 

申请注册联系人电话:

Applicant telephone:

+86 13359017168 

研究负责人电话:

Study leader's telephone:

+86 0551 62283526 

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:

1059237428@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

ysdcwsd@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:

安徽省合肥市庐阳区庐江路17号 

研究负责人通讯地址:

安徽省合肥市庐阳区庐江路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:

230001 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

安徽省立医院 

Applicant's institution:

Department of Geriatrics, Anhui Provincial 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:

NA 

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:

安徽省立医院临床研究伦理委员会 

Name of the ethic committee:

Clinical research ethics committee of Anhui Provincial Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-12-09 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

安徽省立医院 

Primary sponsor:

Anhui Provincial Hospital 

研究实施负责(组长)单位地址:

安徽省合肥市庐阳区庐江路17号 

Primary sponsor's address:

17 Lujiang Road, Luyang District, Hefei, Anhui, 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):

安徽

市(区县):

Country:

China

Province:

Anhui

City:

单位(医院):

安徽省立医院

具体地址:

安徽省合肥市庐阳区庐江路17号

Institution
hospital:

Anhui Provincial Hospital

Address:

17 Lujiang Road, Luyang District, Hefei, Anhui, China

经费或物资来源:

自费 

Source(s) of funding:

own expense 

研究疾病:

2型糖尿病 

Target disease:

T2DM 

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:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

探讨常用的抗糖尿病药物二甲双胍、吡格列酮及西格列汀对T2DM患者动脉粥样硬化的改善作用 

Objectives of Study:

To investigate the effect of commonly used anti diabetic drug metformin, pioglitazone and sitagliptin on atherosclerosis in patients with T2DM  

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:

所有患者均符合WHO-1999年的2型糖尿病诊断标准,2015-1016年安徽省立医院体检中心的患者,糖尿病病程1-5年 

Inclusion criteria

We enrolled 176 T2DM patients (160 male and 16 female) at Anhui Provincial Hospital Medical Center (Hefei, China) during the period of January 2015 and November. All of the enrolled T2DM patients met the WHO-1999 T2DM diagnostic criteria. The duration of diabetes was 1-5 years.  

排除标准:

严重肝肾功能衰竭;心功能3-4级;系统免疫性疾病;慢性感染性疾病和肿瘤;严重糖尿病并发症;2个月内急性应激状态(外科手术,急性感染);他汀类药物及ACEI,ARB药物服用 

Exclusion criteria:

The following criteria were used for excluding patients: severe hepatic and kidney dysfunction; cardiac function grade 3-4; any systemic immune disorders; chronic inflammatory disease or tumor; severe diabetic complications; or an acute stress state within 2 months (surgical operation, active infection). Statin, ARB (angiotensin receptor blocker), and ACEI (angiotensin converting enzyme inhibitor) had not been taken. 

研究实施时间:

Study execute time:

From2015-01-01To 2016-11-30 

征募观察对象时间:

Recruiting time:

From2015-01-01To 2016-11-30 

干预措施:

Interventions:

组别:

Case series

样本量:

176

Group:

Case series

Sample size:

干预措施:

二甲双胍、吡格列酮及西格列汀

干预措施代码:

Intervention:

metformin, pioglitazone and sitagliptin

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

安徽 

市(区县):

 

Country:

China 

Province:

Anhui 

City:

 

单位(医院):

安徽省立医院 

单位级别:

三级甲等 

Institution
hospital:

Anhui Provincial Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

空腹血糖

指标类型:

主要指标 

Outcome:

Fasting Blood Glucose

Type:

Primary indicator 

测量时间点:

清晨8时

测量方法:

生化仪

Measure time point of outcome:

8Am

Measure method:

Biochemical analyzer

指标中文名:

糖化血红蛋白

指标类型:

主要指标 

Outcome:

Hemoglobin A1c (HbA1c)

Type:

Primary indicator 

测量时间点:

清晨8时

测量方法:

生化仪

Measure time point of outcome:

8Am

Measure method:

Biochemical analyzer

指标中文名:

甘油三酯

指标类型:

主要指标 

Outcome:

Triglycerides (TG)

Type:

Primary indicator 

测量时间点:

清晨8时

测量方法:

生化仪

Measure time point of outcome:

8Am

Measure method:

Biochemical analyzer

指标中文名:

总胆固醇

指标类型:

主要指标 

Outcome:

Total Cholesterol (TC)

Type:

Primary indicator 

测量时间点:

清晨8时

测量方法:

生化仪

Measure time point of outcome:

8Am

Measure method:

Biochemical analyzer

指标中文名:

低密度脂蛋白

指标类型:

主要指标 

Outcome:

Low Density Lipoproteins (LDL)

Type:

Primary indicator 

测量时间点:

清晨8时

测量方法:

生化仪

Measure time point of outcome:

8Am

Measure method:

Biochemical analyzer

指标中文名:

高密度脂蛋白

指标类型:

主要指标 

Outcome:

High Density Lipoproteins (HDL)

Type:

Primary indicator 

测量时间点:

清晨8时

测量方法:

生化仪

Measure time point of outcome:

8Am

Measure method:

Biochemical analyzer

指标中文名:

尿酸

指标类型:

主要指标 

Outcome:

Uric Acid (UA)

Type:

Primary indicator 

测量时间点:

清晨8时

测量方法:

生化仪

Measure time point of outcome:

8Am

Measure method:

Biochemical analyzer

指标中文名:

血肌酐

指标类型:

主要指标 

Outcome:

Creatinine (Cr)

Type:

Primary indicator 

测量时间点:

清晨8时

测量方法:

生化仪

Measure time point of outcome:

8Am

Measure method:

Biochemical analyzer

指标中文名:

颈动脉内膜中层厚度

指标类型:

主要指标 

Outcome:

CCA-IMT

Type:

Primary indicator 

测量时间点:

上午9-10

测量方法:

颈动脉彩超

Measure time point of outcome:

9Am-10Am

Measure method:

Carotid artery ultrasonography

指标中文名:

收缩压

指标类型:

主要指标 

Outcome:

recorded Systolic Pressure (SBD)

Type:

Primary indicator 

测量时间点:

清晨8时

测量方法:

电子血压计

Measure time point of outcome:

8Am

Measure method:

Electronic sphygmomanometer

指标中文名:

身高

指标类型:

主要指标 

Outcome:

height

Type:

Primary indicator 

测量时间点:

清晨8时

测量方法:

电子测量仪

Measure time point of outcome:

8Am

Measure method:

Electronic measuring instrument

指标中文名:

体重

指标类型:

主要指标 

Outcome:

weight

Type:

Primary indicator 

测量时间点:

清晨8时

测量方法:

电子测量仪

Measure time point of outcome:

8Am

Measure method:

Electronic measuring instrument

指标中文名:

白介素-6

指标类型:

主要指标 

Outcome:

Serum IL-6

Type:

Primary indicator 

测量时间点:

下午3-5

测量方法:

酶联免疫吸附测定

Measure time point of outcome:

3-5pm

Measure method:

ELISA

指标中文名:

脂联素

指标类型:

主要指标 

Outcome:

ADPN

Type:

Primary indicator 

测量时间点:

下午3-5

测量方法:

酶联免疫吸附测定

Measure time point of outcome:

3-5pm

Measure method:

ELISA

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

1年

Fate of sample:

Preservation after use 

Note:

1year

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 42 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):

根据患者所用降糖药物的不同进行分组

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

Grouped according to the different hypoglycemic drugs used by patients

盲法:

Blinding:

试验完成后的统计结果(上传文件):

点击下载

Calculated Results after
the Study Completed(upload file):

download

是否共享原始数据:

IPD sharing

是Yes

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):

试验完成后6个月内公开,可以通过我的电子邮件索取1059237428@qq.com

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

within six months after the trial complete,Can be obtained through my email 1059237428@qq.com

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:

原始对比检测记录数据,采用Excel表格保存

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

The original contrast detection record data, using Excel table to save

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2017-03-10
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