真实世界临床诊疗代谢相关脂肪性肝病(MAFLD)的前瞻性队列研究

注册号:

Registration number:

ITMCTR2200006552

最近更新日期:

Date of Last Refreshed on:

2022-08-31

注册时间:

Date of Registration:

2022-08-31

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

真实世界临床诊疗代谢相关脂肪性肝病(MAFLD)的前瞻性队列研究

Public title:

A prospective cohort study of real-world clinical diagnosis and treatment of metabolic related fatty liver disease (MAFLD)

注册题目简写:

English Acronym:

研究课题的正式科学名称:

真实世界临床诊疗代谢相关脂肪性肝病(MAFLD)的前瞻性队列研究

Scientific title:

A prospective cohort study of real-world clinical diagnosis and treatment of metabolic related fatty liver disease (MAFLD)

研究课题的正式科学名称简写:

Scientific title acronym:

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:

ChiCTR2200063127 ; ChiMCTR2200006552

申请注册联系人:

彭苗

研究负责人:

肖明中

Applicant:

Miao Peng

Study leader:

Mingzhong Xiao

申请注册联系人电话:

Applicant telephone:

18186159874

研究负责人电话:

Study leader's telephone:

18908640865

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:

zhangserious@outlook.com

研究负责人电子邮件:

Study leader's E-mail:

309452513@qq.com

申请单位网址(自愿提供):

Study leader's 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:

湖北省武汉市洪山区珞喻路856号湖北省中医院肥胖专科

研究负责人通讯地址:

湖北省武汉市洪山区珞喻路856号湖北省中医院肥胖专科

Applicant address:

Obesity Department of Hubei Provincial Hospital of traditional Chinese medicine, No. 856 Luoyu Road, Hongshan District, Wuhan City, Hubei Province

Study leader's address:

Obesity Department of Hubei Provincial Hospital of traditional Chinese medicine, No. 856 Luoyu Road, Hongshan District, Wuhan City, Hubei Province

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:

湖北省中医院

Applicant's institution:

Hubei Provincial Hospital of traditional Chinese Medicine

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

HBZY2022-C09-01、HBZY2022-C09-02

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

湖北省中医院伦理委员会

Name of the ethic committee:

Ethics Committee of Hubei traditional Chinese medicine hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2022/5/31 0:00:00

伦理委员会联系人:

张馨

Contact Name of the ethic committee:

Xin Zhang

伦理委员会联系地址:

湖北省武汉市武昌区花园山4号

Contact Address of the ethic committee:

No. 4 Huayuan mountain, Wuchang District, Wuhan City, Hubei Province

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:

湖北省中医院

Primary sponsor:

Hubei Provincial Hospital of traditional Chinese Medicine

研究实施负责(组长)单位地址:

湖北省武汉市洪山区珞喻路856号湖北省中医院

Primary sponsor's address:

Hubei Provincial Hospital of traditional Chinese medicine, No. 856 Luoyu Road, Hongshan District, Wuhan City, Hubei Province

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

市(区县):

武汉

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

湖北省中医院

具体地址:

武汉市洪山区珞瑜路856号

Institution
hospital:

Hubei Provincial Hospital of traditional Chinese Medicine

Address:

No. 856, Luoyu Road, Hongshan District, Wuhan

经费或物资来源:

研究者自筹

Source(s) of funding:

Self financing by researchers

研究疾病:

代谢相关脂肪性肝病

研究疾病代码:

Target disease:

metabolic associated fatty liver disease, MAFLD

Target disease code:

研究类型:

Study type:

观察性研究

Observational study

研究设计:

Study design:

队列研究

Cohort study

研究所处阶段:

Study phase:

其它

Others

研究目的:

团队前期临床应用中西医结合方法治疗肥胖病和肥胖相关代谢性疾病摸索出了一套行之有效的方法,对于MAFLD人群的体重控制效果明显,建立MAFLD患者队列,对MAFLD人群的真实世界临床诊疗方案开展监测、观察多种MAFLD发生脂肪性肝炎、肝纤维化、肝硬化的发病率,总结多种诊疗方案对于MAFLD人群进展脂肪性肝炎、肝纤维化等结局的有效性、安全性,为中医综合诊疗方案防治青少年以及成年MAFLD疾病提供循证数据,探讨临床诊疗有效性的机制。

Objectives of Study:

The team has explored a set of effective methods for the treatment of obesity and obesity-related metabolic diseases by clinical application of integrated traditional Chinese and Western medicine in the early stage. The program carries out monitoring, observes the incidence of steatohepatitis, liver fibrosis, and cirrhosis of various MAFLDs, and summarizes the effectiveness and safety of various diagnosis and treatment programs for the progression of steatohepatitis, liver fibrosis and other outcomes in MAFLD population. The comprehensive diagnosis and treatment program provides evidence-based data for the prevention and treatment of adolescent and adult MAFLD disease to explore the mechanism of clinical diagnosis and treatment effectiveness.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

1.诊断标准 MAFLD的诊断[1]基于肝脏脂肪变性(通过肝脏组织学、影像学或无创生物标记物检测)通过影像学检测确诊肝脏脂肪变性,同时至少存在以下三项标准之一,其中包括: (1)超重或肥胖; (2)2型糖尿病(T2DM); (3)至少存在两项代谢异常风险因素: a.腰围:亚洲男性≥90cm,女性≥80cm b.血压:≥130/85mmHg或接受特异性药物治疗 c.甘油三酯:≥1.7mmol/L或接受特异性药物治疗 d.高密度脂蛋白胆固醇:男性<1.0女性<1.3mmol/L或接受特异性药物治疗 e.糖尿病前期:空腹血糖5.6~6.9mmol/L或餐后血糖7.8~11.0mmol/L或糖化血红蛋白为5.7~6.4% f.稳态模型评估-胰岛素抵抗指数:HOMA-IR≥2.5 g.血液超敏C反应蛋白:CRP>2mg/L 2.纳入标准 1)年龄:10-65周岁,性别不限; 2)符合上述代谢相关脂肪性肝病 (MAFLD) 的诊断标准; 3)依从性较好,愿意遵守随访原则; 4)同意签署知情同意书; 5) 符合以上全部条件方可参加本项研究。

Inclusion criteria

1. Diagnostic criteria The diagnosis of MAFLD[1] is based on hepatic steatosis (detected by liver histology, imaging, or non-invasive biomarkers) and the presence of at least one of the following three criteria, including: (1) Overweight or obese; (2) Type 2 diabetes (T2DM); (3) There are at least two risk factors for abnormal metabolism: a. Waist circumference: Asian men ≥ 90cm, women ≥ 80cm b. Blood pressure: ≥130/85mmHg or receive specific drug treatment c. Triglyceride: ≥1.7mmol/L or receive specific drug treatment d. High-density lipoprotein cholesterol: male <1.0 female <1.3mmol/L or receiving specific drug treatment e. Pre-diabetes: fasting blood glucose 5.6~6.9mmol/L or postprandial blood glucose 7.8~11.0mmol/L or glycosylated hemoglobin 5.7~6.4% f. Homeostasis Model Assessment - Insulin Resistance Index: HOMA-IR≥2.5 g. Blood high-sensitivity C-reactive protein: CRP>2mg/L 2. Inclusion criteria 1) Age: 10-65 years old, gender is not limited; 2) Meet the above diagnostic criteria for metabolic-associated fatty liver disease (MAFLD); 3) Good compliance, willing to abide by the principle of follow-up; 4) Agree to sign the informed consent; 5) Only those who meet all the above conditions can participate in this study.

排除标准:

排除标准 1)心、肝、肺、肾、脑、血液、神经精神系统等严重疾病,病情未控制者; 2)诊断肝纤维化、肝硬化、酒精性肝病、免疫性肝病及药物性肝脏病变患者; 3)各种恶性肿瘤患者; 4)1月内已经接受过脂肪肝相关诊疗的患者; 5)妊娠或哺乳期妇女; 6)研究者认为不适合参加本研究; 符合以上任意一条则不能参加本项研究。

Exclusion criteria:

Exclusion criteria 1) Serious diseases of the heart, liver, lung, kidney, brain, blood, neuropsychiatric system, etc., whose disease is not under control; 2) Diagnose patients with liver fibrosis, liver cirrhosis, alcoholic liver disease, immune liver disease and drug-induced liver disease; 3) Patients with various malignant tumors; 4) Patients who have received fatty liver related diagnosis and treatment within 1 month; 5) Pregnant or lactating women; 6) The researcher believes that it is not suitable to participate in this research; Anyone who meets any of the above criteria cannot participate in this study.

研究实施时间:

Study execute time:

From 2022-09-01

To      2025-09-01

征募观察对象时间:

Recruiting time:

From 2022-09-01

To      2025-09-01

干预措施:

Interventions:

组别:

未接受中医综合干预方案组

样本量:

300

Group:

Group not receiving comprehensive intervention plan of traditional Chinese Medicine

Sample size:

干预措施:

包括仅接受西医治疗(服用水飞蓟宾、双环醇、多烯磷酰胆碱、甘草酸二铵、熊去氧胆酸等针对肝脏损伤的治疗药物)或未接受任何医学方法干预者

干预措施代码:

Intervention:

Including those who only received Western medical treatment (taking silibinin, bicyclol, polyene phosphorylcholine, diammonium glycyrrhizinate, ursodeoxycholic acid and other drugs for liver damage) or did not receive any medical intervention

Intervention code:

组别:

中医综合干预方案组

样本量:

300

Group:

TCM Integrated Intervention Program Group

Sample size:

干预措施:

(1)中药汤剂:根据中医辨证论治,选用葛根芩连汤、三术一山汤或随证加减。 葛根芩连汤:葛根 黄芩 黄连 甘草 三术一山汤:生白术 炒白术 苍术 山药 中药每日一剂,早晚饭后服用,如实记录具体用药处方、服药持续时间; (2)中医适宜技术: 穴位埋线:选取中脘、天枢、水道、带脉、足三里、丰隆、肝俞、关元等为主穴,根据患者症状随症配穴。10-14天进行1次埋线治疗,3个月为1个周期,如实记录埋线次数; 针刺:选取中脘、天枢、大横、带脉、水道、肝俞为主穴,根据患者症状随症配穴。1周进行2-3次,3个月为1个周期,如实记录针刺次数; 其他适宜技术,如实记载。 (3)服中药间歇性禁食(IF):服中药间歇性禁食疗法(5:2饮食),每周进行1日或2日轻断食,轻断食期间服用中药温阳益气膏(苓桂术甘汤加减),3个月为一个周期,如实记录中药轻断食次数。

干预措施代码:

Intervention:

(1) Chinese herbal decoction: According to TCM syndrome differentiation and treatment, choose Gegen Qinlian Decoction, Sanshu Yishan Decoction or addition and subtraction according to the syndrome. Gegen Qinlian Decoction: Gegen, Scutellaria, Coptidis, Licorice Three Techniques and One Mountain Soup: Raw Atractylodes, Fried Atract

Intervention code:

样本总量 Total sample size : 600

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):

武汉

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

湖北省中医院

单位级别:

省级

Institution/hospital:

Hubei Provincial Hospital of traditional Chinese Medicine

Level of the institution:

provincial level

测量指标:

Outcomes:

指标中文名:

肝脏硬度值

指标类型:

主要指标

Outcome:

LSM

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

丙氨酸氨基转移酶

指标类型:

主要指标

Outcome:

ALT

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

空腹血糖

指标类型:

次要指标

Outcome:

FBG

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血小板计数

指标类型:

主要指标

Outcome:

PLT

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

空腹胰岛素

指标类型:

次要指标

Outcome:

INS

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肿瘤标志物

指标类型:

次要指标

Outcome:

CEA

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

门冬氨酸氨基转移酶

指标类型:

主要指标

Outcome:

AST

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝脏组织病理学评分

指标类型:

主要指标

Outcome:

Liver histopathology score

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:

舌苔样本

组织:

Sample Name:

Tongue coating sample

Tissue:

人体标本去向

使用后保存

说明

保存至我院生物样本库

Fate of sample 

Preservation after use

Note:

标本中文名:

粪便样本

组织:

Sample Name:

Stool sample

Tissue:

人体标本去向

使用后保存

说明

保存至我院生物样本库

Fate of sample 

Preservation after use

Note:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后保存

说明

我院生物样本库

Fate of sample 

Preservation after use

Note:

征募研究对象情况:

尚未开始

Not yet recruiting

年龄范围:

最小 10
Min age years
最大 65
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

依据患者在观察期间是否接受过中医综合干预,将其分为两组:①未接受中医综合干预方案组、②中医综合干预方案组。

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

Patients were divided into two groups according to whether they had received comprehensive intervention of traditional Chinese medicine during the observation period。

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

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):

不共享

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

not shared

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:

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

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

A standard data collection and management system include a CRF and an electronic data capture

数据管理委员会:

Data Managemen Committee:

No

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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