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非酒精性脂肪性肝病相关疾病的临床研究
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注册号:

Registration number:

ChiCTR2000039688 

最近更新日期:

Date of Last Refreshed on:

2020-11-05 

注册时间:

Date of Registration:

2020-11-05 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

非酒精性脂肪性肝病相关疾病的临床研究 

Public title:

Clinical research on non-alcoholic fatty liver disease related diseases 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

非酒精性脂肪性肝病相关心血管病变早期预警风险筛查及诊断试剂盒研发 

Scientific title:

Development of early screening and diagnostic kit for cardiovascular diseases associated with non-alcoholic fatty liver disease 

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:

李钟霖 

研究负责人:

杨玲 

Applicant:

Zhonglin Li 

Study leader:

Ling Yang 

申请注册联系人电话:

Applicant telephone:

15971458102 

研究负责人电话:

Study leader's telephone:

13971178791 

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:

1479590989@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

hepayang@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:

湖北省武汉市江汉区解放大道1277号武汉协和医院 

研究负责人通讯地址:

湖北省武汉市江汉区解放大道1277号武汉协和医院 

Applicant address:

1277 Jiefang Avenue, Wuhan, China 

Study leader's address:

1277 Jiefang Avenue, Wuhan, 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:

华中科技大学附属协和医院 

Applicant's institution:

Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 

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:

S092 

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:

华中科技大学同济医学院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Tongji Medical College, Huazhong University of Science and Technology 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-05-27 

伦理委员会联系人:

李高 

Contact Name of the ethic committee:

Gao Li 

伦理委员会联系地址:

武汉市航空路13号 

Contact Address of the ethic committee:

13 Hangkong Road, Wuhan 

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:

华中科技大学同济医学院附属协和医院 

Primary sponsor:

Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 

研究实施负责(组长)单位地址:

湖北省武汉市江汉区解放大道1277号武汉协和医院 

Primary sponsor's address:

1277 Jiefang Avenue, Wuhan, 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):

湖北省

市(区县):

Country:

China

Province:

Hubei

City:

单位(医院):

华中科技大学同济医学院附属协和医院

具体地址:

湖北省武汉市江汉区解放大道1277号武汉协和医院

Institution
hospital:

Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Address:

1277 Jiefang Avenue, Wuhan, China

经费或物资来源:

省拨经费 

Source(s) of funding:

Province technology funds 

研究疾病:

非酒精性脂肪性肝病 

Target disease:

non-alcoholic fatty liver disease 

研究疾病代码:

 

Target disease code:

 

研究类型:

基础科学研究 

Study type:

Basic Science 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

随着NAFLD疾病的进展会促使心血管疾病、代谢相关疾病、肿瘤等的发病增加。 非酒精性脂肪性肝病相关病变的诊断常在病损发生之后才能确定, 并且没有特异性诊断指标,因此诊断的滞后延误了临床早期干预的最佳时机。 为解决这种困扰, 本项目拟通过以下方面: 在非酒精性脂肪性肝病相关早期心血管病变患者中通过分析循环中肝细胞分泌的囊泡内含物( microRN、 LncRNA 及蛋白质) 、 新型炎症因子、 新型肝细胞分泌因子、 新型脂肪因子、 脂类组学、 胰岛素通路相关蛋白及 microRNA、 LncRNA、 胆汁酸组分、 肠道菌群及其代谢产物进行筛查, 确定单个或多个血清和粪便中具有明确诊断价值的分子, 或肠道菌群及代谢产物,建立 NAFLD 相关病变的风险预警筛查模型, 并且研发 NAFLD 相关病变的早期诊断试剂盒, 早期确定 NAFLD 相关病变的高危患者, 早期进行临床干预, 及时正确地治疗可以阻止 NAFLD 相关病变的进展, 甚至可以使相关病变的病理改变发生逆转, 对降低非酒精性脂肪性肝病患者相关疾病的发生率和死亡率, 提高 NAFLD 相关病变患者的生活质量, 挽救患者生命具有重要意义。 

Objectives of Study:

With the progress of NAFLD disease, the incidence of cardiovascular diseases, metabolic related diseases, tumors accordingly increase. The diagnosis of non-alcoholic fatty liver disease-related lesions is often confirmed after the lesions occur, and there are no specific diagnostic indicators, so the delay in diagnosis misses the best time for early clinical intervention. To solve this problem, the project plans to adopt the following aspects: In patients with early cardiovascular disease related with non-alcoholic fatty liver disease, by analyzing the contents of vesicles (microRN, LncRNA and protein) secreted by hepatocytes in the circulation, new inflammatory factors, new hepatocyte secretory factors, new adipokines, lipids taxonomics, insulin pathway-related proteins and microRNA, lncRNA, bile acid components, intestinal flora and its metabolites are screened to determine single or multiple molecules in serum and stool with clear diagnostic value. We aim to establish early warning screening models for NAFLD-related lesions and develop early diagnosis kits for NAFLD-related lesions. Early identification of high-risk patients with NAFLD-related lesions, early clinical intervention, and timely and correct treatment can prevent NAFLD-related diseases or even reverse the pathological changes of related diseases, which is of great significance for reducing the incidence and mortality of related diseases in patients with non-alcoholic fatty liver disease, improving the life quality of patients with NAFLD-related diseases. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

横断面 

Study design:

Cross-sectional 

纳入标准:

正常组入选标准 1.年龄>18岁,<65岁,性别不限 2.无特殊疾病 3. 有较好依从性的患者 4. 已阅读并签署书面知情同意书 上述问题任一回答是“否”时,该病例不能纳入研究 单纯脂肪肝组入选标准 1.年龄>18岁,<65岁,性别不限 2.B超结果/fibrotouch提示脂肪肝 3.无其他特殊疾病 4. 有较好依从性的患者 5.已阅读并签署书面知情同意书 上述问题任一回答是“否”时,该病例不能纳入研究 脂肪肝合并颈动脉病变组入选标准 1.年龄>18岁,<65岁,性别不限 2.B超结果/fibrotouch提示脂肪肝 3.颈动脉超声提示颈总动脉和颈内动脉 内中膜厚度(IMT)>1.0mm或有颈动脉斑块者 4.有较好依从性的患者 5.已阅读并签署书面知情同意书 上述问题任一回答是“否”时,该病例不能纳入研究 冠心病组入选标准 1.年龄>18岁,<65岁,性别不限 2.已被诊断为冠心病,包括: (1)稳定型心绞痛:心绞痛发作时ST-T段改变,症状消失后改变恢复。冠状动脉CTA提示冠脉病变者。 (2)不稳定型心绞痛和非ST段抬高性心肌梗死:新发或一过性ST段压低≥0.1mV,或T波倒置≥0.2mV);cTnT、cTnI、CK-MB升高;冠脉造影提示相关病变。 (3)急性ST段抬高型心肌梗死:典型的临床表现、心电图改变、实验室检查。 3.B超结果/fibrotouch提示脂肪肝 4.有较好依从性的患者 5.已阅读并签署书面知情同意书 上述问题任一回答是“否”时,该病例不能纳入研究 

Inclusion criteria

Normal group selection criteria 1. Age>18 years old, <65 years old, no gender limit 2. No special disease 3. Patients with better compliance 4. Have read and signed the informed consent If the answer to any of the above questions is "No", the case cannot be included in the study Selection criteria for simple fatty liver group 1. Age>18 years old, <65 years old, no gender limit 2. B-ultrasound results/fibrotouch suggest fatty liver 3. No other special diseases 4. Patients with better compliance 5. Have read and signed the informed consent If the answer to any of the above questions is "No", the case cannot be included in the study Selection criteria for fatty liver combined with carotid artery disease group 1. Age>18 years old, <65 years old, no gender limit 2. B-ultrasound results/fibrotouch suggest fatty liver 3. Carotid artery ultrasound shows common carotid artery and internal carotid artery intima media thickness (IMT)>1.0mm or carotid artery plaque 4. Patients with better compliance 5. Have read and signed the informed consent If the answer to any of the above questions is "No", the case cannot be included in the study Inclusion criteria for coronary heart disease group 1. Age>18 years old, <65 years old, no gender limit 2. Has been diagnosed with coronary heart disease, including: (1) Stable angina pectoris: ST-T segment changes during the onset of angina pectoris, and the change recovers after the symptoms disappear. Coronary artery CTA suggests coronary artery disease. (2) Unstable angina and non-ST-segment elevation myocardial infarction: new or transient ST-segment depression ≥0.1mV, or T wave inversion ≥0.2mV); cTnT, cTnI, CK-MB increase; coronary angiogram revealed related lesions. (3) Acute ST-segment elevation myocardial infarction: typical clinical manifestations, electrocardiogram changes, laboratory examinations. 3. B-ultrasound results/fibrotouch prompts fatty liver 4. Patients with better compliance 5. Have read and signed the informed consent If the answer to any of the above questions is "No", the case cannot be included in the study 

排除标准:

排除标准 1.合并其他心脏疾病(心衰、心瓣膜病、心肌病等)的患者 2.合并其他肝脏疾病(肝癌、肝硬化、乙肝等)的患者 3.合并肺、肾、脑等其他严重器质性病变的患者 上述问题任一回答是“是”时,该病例不能纳入研究 

Exclusion criteria:

Exclusion criteria 1. Patients with other heart diseases (such as heart failure, valvular disease, cardiomyopathy, etc.) 2. Patients with other liver diseases (such as liver cancer, cirrhosis, hepatitis B, etc.) 3. Patients with other serious organic diseases such as lung, kidney, brain If the answer to any of the above questions is "yes", the case cannot be included in the study 

研究实施时间:

Study execute time:

From2020-10-30To 2021-05-27 

征募观察对象时间:

Recruiting time:

From2020-10-30To 2021-05-27 

干预措施:

Interventions:

组别:

正常组

样本量:

55

Group:

Normal group

Sample size:

干预措施:

干预措施代码:

Intervention:

none

Intervention code:

组别:

单纯脂肪肝组

样本量:

55

Group:

Simple fatty liver group

Sample size:

干预措施:

干预措施代码:

Intervention:

none

Intervention code:

组别:

脂肪肝合并颈动脉病变组

样本量:

55

Group:

fatty liver combined with carotid artery disease group

Sample size:

干预措施:

干预措施代码:

Intervention:

none

Intervention code:

组别:

冠心病组

样本量:

55

Group:

Coronary heart disease group

Sample size:

干预措施:

干预措施代码:

Intervention:

none

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

华中科技大学同济医学院附属协和医院 

单位级别:

市级 

Institution
hospital:

Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology  

Level of the institution:

municipal 

测量指标:

Outcomes:

指标中文名:

颈总动脉内中膜厚度

指标类型:

主要指标 

Outcome:

CCA-IMT

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

颈内动脉内中膜厚度

指标类型:

主要指标 

Outcome:

ICA-IMT

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝脏硬度

指标类型:

主要指标 

Outcome:

Liver stiffness

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝脏脂肪衰减值

指标类型:

主要指标 

Outcome:

Liver fat attenuation value

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:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

粪便

组织:

Sample Name:

stool

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

研究者于研究实施地点体检中心随机寻找体检者,征求加入实验,待体检完毕后收集相关数据,并依照纳入排除标准划分组别。

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

The researchers randomly search for volunteers at the physical examination center and collect relevant data after the physical examination is completed, and the volunteers are divided into groups according to inclusion and exclusion criteria.

盲法:

Blinding:

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):

不公开

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

Private

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:

病历记录表、电子采集和管理系统

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

Case Record Form、Electronic Data Capture

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-11-05
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