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常规疗效不佳的高同型半胱氨酸血症协同作用机制及疗效分析
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注册号:

Registration number:

ChiCTR1800020048 

最近更新日期:

Date of Last Refreshed on:

2018-12-12 

注册时间:

Date of Registration:

2018-12-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

常规疗效不佳的高同型半胱氨酸血症协同作用机制及疗效分析  

Public title:

Synergistic mechanism of hyperhomocysteinemia with poor efficacy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

常规疗效不佳的高同型半胱氨酸血症协同作用机制及疗效分析  

Scientific title:

Synergistic mechanism of hyperhomocysteinemia with poor efficacy 

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:

杜晓霞 

研究负责人:

杜晓霞 

Applicant:

Du Xiao-Xia 

Study leader:

Du Xiao-Xia 

申请注册联系人电话:

Applicant telephone:

+86 19910619000 

研究负责人电话:

Study leader's telephone:

+86 19910619000 

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:

364906784@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

364906784@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:

北京市丰台区角门北路10号中国康复研究中心K2  

研究负责人通讯地址:

北京市丰台区角门北路10号中国康复研究中心K2 

Applicant address:

10 Jiaomen Road North, Fengtai District, Beijing, China 

Study leader's address:

10 Jiaomen Road North, Fengtai District, Beijing, 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:

中国康复研究中心 

Applicant's institution:

China Rehabilitation Research Center 

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:

2018-071-1 

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:

中国康复研究中心医学伦理委员会 

Name of the ethic committee:

China Rehabilitation Research Center Medical Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-11-05 

伦理委员会联系人:

乔虹 

Contact Name of the ethic committee:

Qiao Hong 

伦理委员会联系地址:

北京市丰台区角门北路10号 

Contact Address of the ethic committee:

10 Jiaomen Road North, Fengtai District, Beijing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 010-87569876 

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:

中国康复研究中心 

Primary sponsor:

China Rehabilitation Research Center, Beijing Boai Hospital 

研究实施负责(组长)单位地址:

角门北路10号北京丰台区 

Primary sponsor's address:

10 Jiaomen Road North, Fengtai District, Beijing, 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):

北京市

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国康复研究中心

具体地址:

北京市丰台区角门北路10号

Institution
hospital:

China Rehabilitation Research Center, Beijing Boai Hospital

Address:

10 Jiaomen Road North, Fengtai District, Beijing, China

经费或物资来源:

中国康复研究中心北京博爱医院 

Source(s) of funding:

China Rehabilitation Research Center, Beijing Boai Hospital 

研究疾病:

高同型半胱氨酸血症 

Target disease:

hyperhomocysteinemia 

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:

卫生服务研究 

Study phase:

Health Services Research 

研究目的:

新的独立的心脑血管病危险指标-同型半胱氨酸血症(homocysteine,Hcy)越来越多的受到重视和关注。被称为继高血压、高血脂、高血糖等常见动脉硬化危险因素后的“第四高”;高血压、糖尿病、高血脂等脑卒中的传统的危险因素的研究很多,机制较明确。但对于非传统的脑卒中危险因素,如 Hcy 研究较少, Hhcy目前多被认为是心脑血管疾病的一个危险因素,但其作用机制相当复杂,人们对它的认识尚不充分。亚甲基四氢叶酸还(methylenetetrahydrofolate reductase,MTHFR)是叶酸代谢的限速酶,催化5,10-亚甲基四氢叶酸转化为5-甲基四氢叶酸,从而在叶酸代谢、DNA甲基化及修复中起重要作用。携带MTHFRC677T基因型个体与正常人相比,血浆中Hcy的含量增加一倍,部分TT基因型Hhcy患者给予规范化叶酸合用B族维生素效果不佳,本项研究将针对这部分患者的协同基因和代谢进行分析,以期有效治疗。 

Objectives of Study:

The new independent cardiovascular and cerebrovascular disease risk index, homocysteine ??(Hcy), is receiving more and more attention and attention. It is called the fourth high” after the common risk factors of arteriosclerosis such as hypertension, hyperlipemia and hyperglycemia; there are many traditional risk factors for strokes such as hypertension, diabetes and hyperlipidemia, and the mechanism is clear. However, for non-traditional risk factors such as Hcy, Hhcy is currently considered to be a risk factor for cardiovascular and cerebrovascular diseases, but its mechanism of action is quite complex, and people's understanding of it is still insufficient. Methylenetetrahydrofolate reductase (MTHFR) is the rate-limiting enzyme in folate metabolism, catalyzing the conversion of 5,10-methylenetetrahydrofolate to 5-methyltetrahydrofolate, which is involved in folate metabolism and DNA methylation. It plays an important role in the transformation and repair. Compared with normal subjects, individuals with MTHFRC677T genotype doubling the amount of Hcy in plasma. Some patients with TT genotype Hhcy were not well treated with standardized folic acid and B vitamins. This study will focus on the synergistic genes and metabolism of this group of patients. Analyze for effective treatment. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

病房和门诊Hhcy患者,可以规律服药并按照时间点采血,无严重肝肾功能不全,并签署知情同意书。序贯入组Hhcy患者,填写CRF,测定基线HCY/叶酸/VB12/肝肾功 ;叶酸,维生素B6,甲钴胺常规治疗1个月后复查Hcy水平,筛选出降幅小于20%或未达正常值 (60例)。随机分为常规治疗组和联合治疗组。 

Inclusion criteria

Patients in the ward and outpatient Hhcy can take regular medication and collect blood according to the time point, without severe liver and kidney dysfunction, and sign informed consent. Sequential enrollment in Hhcy patients, fill in CRF, determine baseline HCY / folic acid / VB12 / liver and kidney function; folic acid, vitamin B6, mecobalamin after routine treatment for 1 month, review Hcy levels, screening out less than 20% or not normal Value (60 cases). They were randomly divided into the conventional treatment group and the combination treatment group. 

排除标准:

在外院治疗过HCY的患者不纳入本研究组。 

Exclusion criteria:

Patients who had been treated for HCY in the external hospital were not included in the study group. 

研究实施时间:

Study execute time:

From2018-12-10To 2020-10-01 

征募观察对象时间:

Recruiting time:

From2018-12-10To 2020-05-29 

干预措施:

Interventions:

组别:

联合治疗组

样本量:

30

Group:

Case series

Sample size:

干预措施:

3B治疗+VB2 +甜菜碱

干预措施代码:

Intervention:

B treatment + VB2 + betaine

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京市 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国康复研究中心 

单位级别:

三级甲等医院 

Institution
hospital:

China Rehabilitation Research Center  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

叶酸

指标类型:

主要指标 

Outcome:

Folic acid

Type:

Primary indicator 

测量时间点:

空腹

测量方法:

血液检测

Measure time point of outcome:

Early morning fasting

Measure method:

blood test

指标中文名:

亚甲基四氢叶酸还原酶

指标类型:

主要指标 

Outcome:

Methylenetetrahydrofolate reductase

Type:

Primary indicator 

测量时间点:

空腹

测量方法:

血液检测

Measure time point of outcome:

Early morning fasting

Measure method:

blood test

指标中文名:

蛋氨酸合成酶

指标类型:

次要指标 

Outcome:

Methionine synthase

Type:

Secondary indicator 

测量时间点:

空腹

测量方法:

PCR检测

Measure time point of outcome:

Early morning fasting

Measure method:

PCR

指标中文名:

胱硫醚B合成酶

指标类型:

次要指标 

Outcome:

Cystathionine B synthetase

Type:

Secondary indicator 

测量时间点:

空腹

测量方法:

PCR检测

Measure time point of outcome:

Early morning fasting

Measure method:

PCR

指标中文名:

维生素B12

指标类型:

主要指标 

Outcome:

vitamin B12

Type:

Primary indicator 

测量时间点:

空腹

测量方法:

PCR检测

Measure time point of outcome:

Early morning fasting

Measure method:

PCR

采集人体标本:

Collecting sample(s)
from participants:

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 80 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):

N/A

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

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

否No

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):

电脑录入

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

Computer entry

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, CRF

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2018-12-12
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