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益生菌干预IGT向糖尿病转化的多中心随机双盲安慰剂对照研究
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注册号:

Registration number:

ChiCTR-TRC-13004024 

最近更新日期:

Date of Last Refreshed on:

2016-06-19 

注册时间:

Date of Registration:

2013-12-23 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

益生菌干预IGT向糖尿病转化的多中心随机双盲安慰剂对照研究 

Public title:

A multicenter, randomized, double-blind, placebo-controlled clinical trial of the efficacy of probiotic intervention in preventing the conversion of impaired glucose tolerance (IGT) to type 2 diabetes mellitus 

研究课题的正式科学名称:

益生菌干预IGT向糖尿病转化的多中心随机双盲安慰剂对照研究 

Scientific title:

A multicenter, randomized, double-blind, placebo-controlled clinical trial of the efficacy of probiotic intervention in preventing the conversion of impaired glucose tolerance (IGT) to type 2 diabetes mellitus 

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:

晏群 

研究负责人:

冯波 

Applicant:

Qun Yan 

Study leader:

Bo Feng 

申请注册联系人电话:

Applicant telephone:

+86 13774419761 

研究负责人电话:

Study leader's telephone:

+86 13301921056 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

+86-21-58793427 

申请注册联系人电子邮件:

Applicant E-mail:

yanqun120811@126.com 

研究负责人电子邮件:

Study leader's E-mail:

fengbo@medmail.com.cn 

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:

上海市浦东新区即墨路150号东方医院8东内分泌科 

研究负责人通讯地址:

上海市浦东新区即墨路150号东方医院8东内分泌科 

Applicant address:

150 Ji-mo Road, Shanghai, China 

Study leader's address:

150 Ji-mo Road, Shanghai, China 

申请注册联系人邮政编码:

Applicant postcode:

200120 

研究负责人邮政编码:

Study leader's postcode:

200120 

申请人所在单位:

上海市东方医院(同济大学附属东方医院) 

Applicant's institution:

Department of Endocrinology, Shanghai East Hospital, Tongji University School of Medicine, China. 

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:

(2013)伦审第(009)号 

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:

上海市东方医院(同济大学附属东方医院)医学伦理委员会 

Name of the ethic committee:

ethic committee of Shanghai East Hospital, Tongji University School of Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-12-16 

研究实施负责(组长)单位:

上海市东方医院(同济大学附属东方医院)内分泌科 

Primary sponsor:

Department of Endocrinology, Shanghai East Hospital, Tongji University School of Medicine, China. 

研究实施负责(组长)单位地址:

上海市浦东新区即墨路150号东方医院内分泌科 

Primary sponsor's address:

150 Ji-mo Road, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市东方医院(同济大学附属东方医院)

具体地址:

上海市浦东新区即墨路150号

Institution
hospital:

Shanghai East Hospital

Address:

150 Ji-mo Road, Shanghai, China

经费或物资来源:

公司赞助 

Source(s) of funding:

company fund 

研究疾病:

糖耐量异常,2型糖尿病 

Target disease:

Impaired glucose tolerance, Type 2 diabetes mellitus 

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:

其它 

Study phase:

Other 

研究目的:

了解益生菌对糖耐量异常患者转化为2型糖尿病的影响 

Objectives of Study:

To study the efficacy of probiotic intervention in preventing the conversion of impaired glucose tolerance to type 2 diabetes mellitus. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照试验 

Study design:

Randomized parallel controlled trial 

纳入标准:

1.年龄在35-65岁之间,男女不限;2.经OGTT试验明确的IGT患者,无其它严重的合并症,无严重的器官障碍;3.患者要签署《受试者知情同意书》;4.同意治疗期间不使用其他针对IGT的药物治疗。 

Inclusion criteria

1. Aged 35-65 years; 2. Diagnose IGT after OGTT, no serious heart, liver, kidney, lung dysfunction; 3. Informed consent; 4. Agreement on no other drug therapy on IGT during trial. 

排除标准:

1.患有严重肝、肾、心脏、神经系统疾病的患者;确诊糖尿病者;2.对培菲康药物及本品组成成分过敏,或使用与本病疗效有关的药物或疗法者;3.怀疑或确有酒精、药物滥用病史,或根据研究者的判断具有降低入组可能性或使入组复杂化的其他病变,如工作环境经常变动等已造成失访的情况;4.近3个月参加过其他临床试验观察的患者;5.观察者认为应排除此项观察的其他任何情况或疾病患者。 

Exclusion criteria:

1. No serious heart, liver, kidney, lung dysfunction, no diabetes; 2. Probiotic allergy; 3. Suspected or confirmed history of alcohol, drug abuse, or may change the work environment frequently according to the investigator's judgment; 4. Have participated in other clinical trials in the past three months; 5. Some other possible situations not suitable to this trial judged by observers. 

研究实施时间:

Study execute time:

From2014-01-01To 2016-12-31 

干预措施:

Interventions:

组别:

干预组

样本量:

100

Group:

treatment group

Sample size:

干预措施:

口服益生菌

干预措施代码:

Intervention:

oral probiotic

Intervention code:

组别:

对照组

样本量:

100

Group:

control group

Sample size:

干预措施:

口服安慰剂

干预措施代码:

Intervention:

oral placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市东方医院(同济大学附属东方医院) 

单位级别:

三级甲等 

Institution
hospital:

Shanghai East Hospital, Tongji University School of Medicine  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

血糖

指标类型:

主要指标 

Outcome:

blood glucose

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:

次要指标 

Outcome:

lipids

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝肾功能

指标类型:

副作用指标 

Outcome:

liver and kidney function

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胰岛功能

指标类型:

附加指标 

Outcome:

beta cell function

Type:

Additional 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:

附加指标 

Outcome:

HbA1C

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

脂多糖

指标类型:

附加指标 

Outcome:

LPS

Type:

Additional 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 35 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):

由统计学专家利用SPSS13.0产生数字随机表;以按顺序编码,不透亮、密封的信封进行隐匿分组

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

Random number table is performed with SPSS 13.0 by statistical expert.groups are divided with the or

盲法:

Blinding:

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):

上海市东方医院(同济大学附属东方医院)

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

Not stated

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:

上海市东方医院(同济大学附属东方医院)

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

Not stated

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2013-12-23
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