今天是:2019-01-21 星期一

以GLP-1为基础的药物对初发肥胖2型糖尿病患者胰岛素抵抗的改善及作用机制研究
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注册号:

Registration number:

ChiCTR1900020647 

最近更新日期:

Date of Last Refreshed on:

2019-01-11 

注册时间:

Date of Registration:

2019-01-11 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

以GLP-1为基础的药物对初发肥胖2型糖尿病患者胰岛素抵抗的改善及作用机制研究 

Public title:

Study for GLP-1-based drugs on improving insulin sensitivity in newly diagnosis obese type 2 diabetic patients 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

以GLP-1为基础的药物对初发肥胖2型糖尿病患者胰岛素抵抗的改善及作用机制研究 

Scientific title:

Study for GLP-1-based drugs on improving insulin sensitivity in newly diagnosis obese type 2 diabetic 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:

施梦特 

研究负责人:

施梦特 

Applicant:

Shi Mengte 

Study leader:

Shi Mengte 

申请注册联系人电话:

Applicant telephone:

+86 13706673733 

研究负责人电话:

Study leader's telephone:

+86 13706673733 

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:

smt198853@163.com 

研究负责人电子邮件:

Study leader's E-mail:

smt198853@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:

中国浙江省温州市学院西路109号 

研究负责人通讯地址:

中国浙江省温州市学院西路109号 

Applicant address:

109 Xueyuan Road West, Wenzhou, Zhejiang, China 

Study leader's address:

109 Xueyuan Road West, Wenzhou, Zhejiang, 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:

温州医科大学附属第二医院 

Applicant's institution:

Department of Endocrinology, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical 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:

KYKT2018-112 

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:

温州医科大学附属第二医院医学伦理委员会 

Name of the ethic committee:

the ethics committee of The Second Affiliated Hospital of Wenzhou Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

朱雪琼 

Contact Name of the ethic committee:

Zhu Xueqiong 

伦理委员会联系地址:

中国浙江省温州市学院西路109号 

Contact Address of the ethic committee:

109 Xueyuan Road West, Wenzhou, Zhejiang, 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:

温州医科大学附属第二医院 

Primary sponsor:

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University 

研究实施负责(组长)单位地址:

中国浙江省温州市学院西路109号 

Primary sponsor's address:

109 Xueyuan Road West, Wenzhou, Zhejiang, 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):

浙江省

市(区县):

温州市

Country:

China

Province:

Zhejiang

City:

Wenzhou

单位(医院):

温州医科大学附属第二医院

具体地址:

中国浙江省温州市学院西路109号

Institution
hospital:

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Address:

109 Xueyuan Road West, Wenzhou, Zhejiang, China

经费或物资来源:

温州医科大学附属第二医院 

Source(s) of funding:

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University 

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 study 

研究所处阶段:

上市后药物 

Study phase:

Post-market 

研究目的:

本研究围绕关键问题“以GLP-1为基础的药物能否改善肥胖2型糖尿病患者骨骼肌微循环容量和胰岛素抵抗状态”,为其改善胰岛素抵抗作用机制提供相关的临床依据,对制定该类药物更完善的临床适用范围起到一定理论依据。 

Objectives of Study:

To investigate the influence of GLP-1-based drugs on the muscular microcirculation and insulin resistance in in newly diagnosed obese type 2 diabetic patients, proving the basis for its improvement in insulin sensitivity,formulating a better clinical application of this kind of drugs. 

药物成份或治疗方案详述:

利拉鲁肽:二甲双胍;亚莫利 

Description for medicine or protocol of treatment in detail:

Liraglutide;Metformin; glimepiride 

研究设计:

随机平行对照试验 

Study design:

Randomized parallel controlled trial 

纳入标准:

a.初诊2型糖尿病患者40名; b.年龄:18~65岁; c.3月内无糖尿病急性代谢并发症; d.BMI:25~35Kg/m2; e.HbA1c:7.5%~10.0% f.FPG:7~13.9mmol/L,2hPG≥11.1mmol/L g.TG≤5mmol/L 

Inclusion criteria

1. type 2 diabetes newly diagnosed within 6-12 months; 2. aged 18-65 years; 3. No diabetic acute metabolic complications within 3 months; 4. 7.5% ≤ HbA1c ≤ 10.0%; 5. BMI 25-35kg/m2; 6. FPG:7~13.9mmol/L2hPG≥11.1mmol/L; 7. TG≤5mmol/L. 

排除标准:

a.1型糖尿病; b.正在使用降脂药治疗者; c.除二甲双胍外,(招募前)使用Exenatide、Liraglutide或其他促胰岛素能方案治疗; d.主要心血管疾病(如心衰、不稳定性心绞痛、心梗、高血压180/105mmHg以上); e.妊娠、哺乳期、计划怀孕者 

Exclusion criteria:

1. Treatment with cholesterol-lowering drugs before recruitment; 2. Treatment with Exenatide, Liraglutide or other incretinergic regimen (before recruitment) except Metformin; 3. Severe renal, liver or heart disease; 4. Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods. 

研究实施时间:

Study execute time:

From2019-01-01To 2020-12-31 

干预措施:

Interventions:

组别:

A

样本量:

20

Group:

A

Sample size:

干预措施:

利拉鲁肽+二甲双胍

干预措施代码:

Intervention:

Liraglutide+Metformin

Intervention code:

组别:

B

样本量:

20

Group:

B

Sample size:

干预措施:

亚莫利+二甲双胍

干预措施代码:

Intervention:

glimepiride+Metformin

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江省 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

温州医科大学附属第二医院 

单位级别:

三甲 

Institution
hospital:

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

骨骼肌的微血管血流灌注量

指标类型:

主要指标 

Outcome:

muscle microvascular blood flow

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肱动脉缺血后内皮依赖舒张功能

指标类型:

主要指标 

Outcome:

brachial flow mediated dilatation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

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:

肝功能

指标类型:

次要指标 

Outcome:

Liver function

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 levels

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:

Body mass index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血炎症指标

指标类型:

次要指标 

Outcome:

blood inflammatory markers

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

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 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):

随机数字表

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

Random number table

盲法:

未说明

Blinding:

Not stated

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:

即时公开/Real time access

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):

联系研究负责人E-mail获取原始数据

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

Study leader's E-mail

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:

病例记录表

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

Case Record Form

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-01-11
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