今天是:2019-07-21 星期日

二甲双胍药物不良反应的影响因素及与基因多态性的相关性研究
下载XML文档

注册号:

Registration number:

ChiCTR1900023116 

最近更新日期:

Date of Last Refreshed on:

2019-05-12 

注册时间:

Date of Registration:

2019-05-11 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

二甲双胍药物不良反应的影响因素及与基因多态性的相关性研究  

Public title:

Study for the influencing factors of adverse drug reaction of metformin and its correlation with gene polymorphism 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

二甲双胍药物不良反应的影响因素及与基因多态性的相关性研究 

Scientific title:

Study for the influencing factors of adverse drug reaction of metformin and its correlation with gene polymorphism 

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:

刘东方 

研究负责人:

刘东方 

Applicant:

Dongfang Liu 

Study leader:

Dongfang Liu 

申请注册联系人电话:

Applicant telephone:

+86 18623407751 

研究负责人电话:

Study leader's telephone:

+86 18623407751 

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:

ldf023023@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

ldf023023@qq.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:

重庆市渝中区临江路76号 

研究负责人通讯地址:

重庆市渝中区临江路76号 

Applicant address:

76 Linjiang Road, Yuzhong District, Chongqing, China 

Study leader's address:

76 Linjiang Road, Yuzhong District, Chongqing, China 

申请注册联系人邮政编码:

Applicant postcode:

4000010 

研究负责人邮政编码:

Study leader's postcode:

4000010 

申请人所在单位:

重庆医科大学附属第二医院 

Applicant's institution:

The Second Hospital Affiliated to Chongqing 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:

科伦预审第(2019)276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:

重庆医科大学附属第二医院伦理委员会 

Name of the ethic committee:

Ethics Committee of the Second Affiliated Hospital of Chongqing Medical University  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-04-26 

伦理委员会联系人:

吴明珍 

Contact Name of the ethic committee:

Mingzhen Wu 

伦理委员会联系地址:

中国重庆市渝中区临江路76号 

Contact Address of the ethic committee:

76 Linjiang Road, Yuzhong District, Chongqing, 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:

重庆医科大学附属第二医院 

Primary sponsor:

The Second Hospital Affiliated to Chongqing Medical University 

研究实施负责(组长)单位地址:

重庆市渝中区临江路76号 

Primary sponsor's address:

76 Linjiang Road, Yuzhong District, Chongqing, 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):

重庆市

市(区县):

渝中区

Country:

China

Province:

Chongqing

City:

Yuzhong District

单位(医院):

重庆医科大学附属第二医院

具体地址:

临江路76号

Institution
hospital:

The Second Hospital Affiliated to Chongqing Medical University

Address:

76 Linjiang Road

经费或物资来源:

课题经费 

Source(s) of funding:

Research funding 

研究疾病:

代谢性疾病 

Target disease:

Metabolic diseases 

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:

探索性研究/预试验 

Study phase:

研究目的:

探索影响二甲双胍药物代谢、血药浓度、药物不良反应的基因多态性,以期为实现二甲双胍的个体化、精准化治疗提供临床指导意义。 

Objectives of Study:

By explore the correlation of gene polymorphisms with drug metabolism, blood drug concentration and adverse drug reactions of metformin, we hope to provide clinical guidance for the individualized and precise treatment of metformin. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1. 初诊为2型糖尿病的患者; 2. 降糖及其他用药方案稳定8周及以上的2型糖尿病患者; 3. 拟用二甲双胍治疗的高胰岛素血症/多囊卵巢综合征患者。 

Inclusion criteria

1. patients newly diagnosed with type 2 diabetes; 2. Patients with type 2 diabetes whose blood glucose and other drug regimens have been stable for 8 weeks or more; 3. Patients with hyperinsulinemia/polycystic ovary syndrome who are proposed to be treated with metformin. 

排除标准:

1. 糖尿病合并妊娠; 2. 合并糖尿病性酮症、酮症酸中毒、乳酸酸中毒、高渗高糖昏迷、急性胰腺炎等急性并发症; 3. 严重肝肾功能不全; 4. 对双胍类药物过敏者; 5. 有严重胃肠道疾病或近2周服用引起胃肠道障碍的药物、食物; 6. 合并肿瘤、免疫系统疾病者。 

Exclusion criteria:

1. diabetes mellitus with pregnancy; 2. diabetic ketosis, ketoacidosis, lactic acidosis, hyperosmolar hyperglycemia coma, acute pancreatitis and other acute complications; 3. severe hepatorenal insufficiency; 4. allergic to biguanides; 5. have severe gastrointestinal diseases or take medicine or food causing gastrointestinal disorders for nearly 2 weeks; 6. patients with tumor and immune system diseases. 

研究实施时间:

Study execute time:

From2019-05-11To 2020-12-31 

干预措施:

Interventions:

组别:

试验组

样本量:

90

Group:

The experimental group

Sample size:

干预措施:

二甲双胍

干预措施代码:

Intervention:

Metformin

Intervention code:

组别:

对照组

样本量:

30

Group:

The control group

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

The placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆市 

市(区县):

渝中区 

Country:

China 

Province:

Chongqing 

City:

Yuzhong District 

单位(医院):

重庆医科大学附属第二医院 

单位级别:

三级甲等 

Institution
hospital:

The Second Hospital Affiliated to Chongqing Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

基因多态性

指标类型:

主要指标 

Outcome:

Gene polymorphism

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胃肠道反应

指标类型:

主要指标 

Outcome:

Gastrointestinal reaction

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体重指数

指标类型:

主要指标 

Outcome:

BMI

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:

Hemoglobin a1c

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血糖

指标类型:

主要指标 

Outcome:

Blood sugar

Type:

Primary 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:

主要指标 

Outcome:

Blood fat

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生化检查

指标类型:

次要指标 

Outcome:

Biochemical examination

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 85 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):

采用随机数字表法将其用随机数字进行编号,随机分配到两组,整个随机过程由第三方统计专家执行,凡直接参与本次的研究人员均不参与本过程。

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

Random number table method was used to number them with random numbers and randomly assigned to two groups. The whole random process was carried out by third-party statistical experts. No researchers who directly participated in this process participated in it.

盲法:

未说明

Blinding:

Not stated

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):

于试验完成后6个月内公开原始数据

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

Raw data will be shared within 6 months after the trial complete

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:

采用电子病例表格进行数据的收集和管理

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

Data are collected and managed by electronic forms

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-05-11
返回列表