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锌alpha2糖蛋白在非酒精性脂肪肝和甲状腺疾病中的表达的病例对照研究
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注册号:

Registration number:

ChiCTR-ROC-17012943 

最近更新日期:

Date of Last Refreshed on:

2017-10-11 

注册时间:

Date of Registration:

2017-10-11 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

锌alpha2糖蛋白在非酒精性脂肪肝和甲状腺疾病中的表达的病例对照研究 

Public title:

A case-control study on the expression of zinc alpha2 glycoprotein in nonalcoholic fatty liver disease and thyroid disease 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

锌alpha2糖蛋白在非酒精性脂肪肝和甲状腺疾病中的表达的病例对照研究 

Scientific title:

A case-control study on the expression of zinc alpha2 glycoprotein in nonalcoholic fatty liver disease and thyroid disease 

研究课题代号(代码):

Study subject ID:

国家自然科学基金(81270925);湖南省卫生计生委科研计划课题(A2017011) 

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:

李骄阳 

研究负责人:

肖新华 

Applicant:

Li Jiao-yang 

Study leader:

Xiao Xin-hua 

申请注册联系人电话:

Applicant telephone:

+86 18573477875 

研究负责人电话:

Study leader's telephone:

+86 13974703153 

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:

ljy_li@163.com 

研究负责人电子邮件:

Study leader's E-mail:

xiaoxinhua139@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

www.nhfyyy.com 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

www.nhfyyy.com 

申请注册联系人通讯地址:

湖南省衡阳市船山路69号 

研究负责人通讯地址:

湖南省衡阳市船山路69号 

Applicant address:

69 Chuanshan Road, Hengyang, Hunan, China 

Study leader's address:

69 Chuanshan Road, Hengyang, Hunan, China 

申请注册联系人邮政编码:

Applicant postcode:

421001 

研究负责人邮政编码:

Study leader's postcode:

421001 

申请人所在单位:

南华大学附属第一医院 

Applicant's institution:

the First Affiliated Hospital of University of South 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:

[2015]05-01 

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:

南华大学附属第一医院药物临床试验伦理委员会 

Name of the ethic committee:

the First Affiliated Hospital of University of South China Ethical Committee on clinical trials of drugs 

伦理委员会批准日期:

Date of approved by ethic committee:

 

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:

南华大学附属第一医院 

Primary sponsor:

the First Affiliated Hospital of University of South China 

研究实施负责(组长)单位地址:

湖南省衡阳市船山路69号 

Primary sponsor's address:

69 Chuanshan Road, Hengyang, Hunan, 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):

湖南省

市(区县):

衡阳市

Country:

China

Province:

Hu'nan

City:

Hengyang

单位(医院):

南华大学附属第一医院

具体地址:

湖南省衡阳市船山路69号

Institution
hospital:

the First Affiliated Hospital of University of South China

Address:

69 Chuanshan Road, Hengyang, Hunan, China

经费或物资来源:

国家自然科学基金(81270925);湖南省卫生计生委科研计划课题(A2017011) 

Source(s) of funding:

National Natural Science Foundation of China (81270925); Major special projects of hunan provincial health and family planning commission(A2017011) 

研究疾病:

非酒精性脂肪肝;甲状腺疾病 

Target disease:

nonalcoholic fatty liver disease; thyroid disease 

研究疾病代码:

K76.001; E05.901 

Target disease code:

K76.001; E05.901 

研究类型:

病因学/相关因素研究 

Study type:

Cause/Relative factors study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

首次探讨锌alpha2糖蛋白(ZAG)在非酒精性脂肪肝(NAFLD)与甲状腺功能亢进患者中的表达及其相关性,为疾病的治疗提供可能的潜在靶点。 

Objectives of Study:

To investigate the expression of Zinc-α2-glycoprotein in patients with nonalcoholic fatty liver disease and thyroid disease, and may provide a new serum marker for the diagnosis of the 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:

单臂 

Study design:

Single arm 

纳入标准:

NAFLD: 1. 18周岁≤年龄≤70周岁,性别不限;经B超确诊的脂肪肝患者,且无过量酒精摄入患者(女性<20g/d, 男性<30g/d);2.自愿参与本研究且签署知情同意书者。 甲状腺功能亢进症: 1.18周岁≤年龄≤70周岁,性别不限;2.存在甲状腺功能亢进症典型临床表现;3.血清甲状腺激素TH水平升高,促甲状腺激素TSH水平降低,TRAb正常或升高;4.第一次被诊断为甲状腺功能亢进症者;自愿参与本研究且签署知情同意书者。 

Inclusion criteria

NAFLD 1. Aged 18 to 70 years; 2. clinically defined as manifestations of B ultrasonography, and No excessive alcohol intake ( female < 20g/d, male < 30g/d); 3. volunteered to participate in the study and signed informed consent; Hyperthyroidism: 1. Aged 18 to 70 years; 2. dignosed with hyperthyroidism by tipical presentation, elevated serum TH, reduced thyroid-stimulating hormone (TSH), but TSH receptor antibody (TRAb) levels in these patients may increased or normal; 3. diagnosed with hyperthyroidism for the first time. 4. volunteered to participate in the study and signed informed consent. 

排除标准:

非酒精性脂肪肝患者:1)年龄小于18周岁;2)意识障碍或行动不能自如者;3)合并严重心、脑、肝、肾等器质性病变者或恶性肿瘤患者;4)有乙肝、肝炎者;5)妊娠或哺乳期妇女; 甲状腺功能亢进症患者:1)年龄小于18周岁;2)BMI大于35 kg/m2;3)肿瘤、糖尿病、吸烟、高血压、肾功能损害(血清肌酐大于120μmol/L)。 

Exclusion criteria:

NAFLD 1. Consciousness disorder or unable to move freely; 2. Severe heart, brain, liver, kidney and other organic lesions or patients with malignant tumors. 3. Hepatitis B and hepatitis; 4. Pregnant or lactating women. Hyperthyroidism: BMI > 35 kg/m2, known cardiovascular disease, neoplasms, smoking, diabetes, hypertension, and renal impairment (serum creatinine 120 μmol/L).  

研究实施时间:

Study execute time:

From2015-09-01To 2015-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

20

Group:

Case series

Sample size:

干预措施:

N/A

干预措施代码:

Intervention:

N/A

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖南 

市(区县):

衡阳 

Country:

China 

Province:

Hu'nan 

City:

Hengyang 

单位(医院):

南华大学附属第一医院 

单位级别:

三甲 

Institution
hospital:

the First Affiliated Hospital of University of South China  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

锌alpha2糖蛋白

指标类型:

主要指标 

Outcome:

Zinc-α2-glycoprotein

Type:

Primary indicator 

测量时间点:

测量方法:

酶联免疫吸附法

Measure time point of outcome:

Measure method:

ELISA

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

使用后保存 

说明

Fate of sample:

Preservation 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 18 years
最大 Max age 78 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:

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):

2018年6月30日前,上传中国临床试验注册中心网站,网址:http://www.chictr.org.cn

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

Before June 30, 2018, upload the website of China Clinical Trials Registry Website: http://www.chictr.org.cn

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:

调查研究的原始纸质记录,包括问卷及相关表格密封存档。所有数据采用SPSS 17.0汇总分析,相关电子记录存入专门的硬盘。所有相关数据由研究组负责人保管。

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

The original paper records of the survey, including questionnaires and related forms, are sealed with a special file cabinet. All data were analyzed using SPSS 17.0, and the relevant electronic records were stored in a dedicated hard disk. All relevant data are kept by the research team leader.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2017-10-11
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