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Actinidia Chinensis Planch improves the indices of antioxidant and anti-inflammation status of Type 2 diabetes mellitus by activating Keap1 and Nrf2 via the upregulation of microRNA-424
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注册号:

Registration number:

ChiCTR-ONC-17011087 

最近更新日期:

Date of Last Refreshed on:

2017-04-07 

注册时间:

Date of Registration:

2017-04-07 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

猕猴桃通过微小RNA-424的上调激活Keap1和Nrf2来改善2型糖尿病的抗氧化和抗炎状态 

Public title:

Actinidia Chinensis Planch improves the indices of antioxidant and anti-inflammation status of Type 2 diabetes mellitus by activating Keap1 and Nrf2 via the upregulation of microRNA-424 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

猕猴桃通过微小RNA-424的上调激活Keap1和Nrf2来改善2型糖尿病的抗氧化和抗炎状态 

Scientific title:

Actinidia Chinensis Planch improves the indices of antioxidant and anti-inflammation status of Type 2 diabetes mellitus by activating Keap1 and Nrf2 via the upregulation of microRNA-424 

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:

孙龙凤 

研究负责人:

孙龙凤 

Applicant:

Longfeng Sun 

Study leader:

Longfeng Sun 

申请注册联系人电话:

Applicant telephone:

+86 13898898686 

研究负责人电话:

Study leader's telephone:

+86 13898898686 

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:

sunlf1012@yeah.net 

研究负责人电子邮件:

Study leader's E-mail:

sunlf1012@yeah.net 

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:

沈阳市和平区南京街155号 

研究负责人通讯地址:

沈阳市和平区南京街155号 

Applicant address:

155 Nanjing Street, Shenyang, Liaoning, China 

Study leader's address:

155 Nanjing Street, Shenyang, Liaoning, 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:

中国医科大学附属第一医院 

Applicant's institution:

The First Affiliated Hospital of China Medical University 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

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:

 

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:

中国医科大学附属第一医院 

Primary sponsor:

The First Affiliated Hospital of China Medical University 

研究实施负责(组长)单位地址:

沈阳市和平区南京街155号 

Primary sponsor's address:

155 Nanjing Street, Shenyang, Liaoning, 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):

辽宁省

市(区县):

Country:

China

Province:

Liaoning

City:

单位(医院):

中国医科大学附属第一医院

具体地址:

沈阳市和平区南京街155号

Institution
hospital:

The First Affiliated Hospital of China Medical University

Address:

155 Nanjing Street, Shenyang, Liaoning, China

经费或物资来源:

自费 

Source(s) of funding:

N/A 

研究疾病:

糖尿病 

Target disease:

Type 2 diabetes mellitus 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

探究猕猴桃改善2型糖尿病的抗氧化和抗炎状态 

Objectives of Study:

To explore the effects of kiwi on the antioxidant and antiinflammatory properties of diabetes patients 

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:

1)患者每天很少消耗水果; 2)正常工作和配偶; 3)他们想加入我们的研究,如接受FJACP治疗; 4)患者被诊断患有T2DM; 5)患者的身体质量指数(BMI)大于25且小于39 kg / m2; 6)其体重在本实验前3个月内稳定。 

Inclusion criteria

1) the patients seldom consumed fruits daily; 2) had normal work and spouse; 3) they wanted to join our research, such as receiving FJACP treatment; 4) the patients were diagnosed with T2DM; 5) the patients had a body mass index (BMI) more than 25 and less than 39 kg/m2; 6) their weight were stable within three months before present experiment. 

排除标准:

1)患者患有老年性痴呆,如帕金森病(PD),阿尔茨海默病(AD)和脑损伤等; 2)患者患有心脏病,高血压,头晕及相关疾病; 3)患者肢体运动障碍; 4)患者临床表现异常明显。 

Exclusion criteria:

1) the patients had senile dementia, such as Parkinson disease (PD), Alzheimer disease (AD) and brain injury so on; 2) the patients suffered from cardiac disorder, hypertension, dizziness and related disorders; 3) the patients had the obstacle for limb movement; 4) the patients had obvious abnormal clinical findings. 

研究实施时间:

Study execute time:

From2015-03-11To 2018-03-01 

干预措施:

Interventions:

组别:

实验组和对照组

样本量:

122

Group:

PG and CG

Sample size:

干预措施:

猕猴桃

干预措施代码:

Intervention:

kiwi fruit

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

辽宁省 

市(区县):

 

Country:

China 

Province:

Liaoning 

City:

 

单位(医院):

中国医科大学附属第一医院 

单位级别:

三甲 

Institution
hospital:

The First Affiliated Hospital of China Medical University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

抗炎因子

指标类型:

主要指标 

Outcome:

inflammatory cytokines

Type:

Primary 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:

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 50 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):

NA

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

NA

盲法:

Blinding:

试验完成后的统计结果(上传文件):

点击下载

Calculated Results ater
the Study Completed(upload file):

download

原始数据公开时间:

The time of sharing IPD:

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):

与通讯作者联系,通过ResMan

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

IPD will be public accessable via ResMan, please contact corresponding author

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:

原始记录和病例单位档案馆保存

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

Original data will be kept at Archives of our institute

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2017-04-07
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