ChiCTR2600119451 版本V1.0 版本创建时间2026/02/27 10:32:50 中国临床试验注册中心

审核状态:

Project audit state:

通过审核

Successful

注册号:

Registration number:

ChiCTR2600119451 

最近更新日期:

Date of Last Refreshed on:

2026-02-27 10:32:30 

注册时间:

Date of Registration:

2026-02-27 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

代谢综合征的院内流行特征及相关疾病风险研究

Public title:

Study on the In-hospital Prevalence Characteristics of Metabolic Syndrome and Associated Disease Risks

注册题目简写:

English Acronym:

研究课题的正式科学名称:

代谢综合征的院内流行特征及相关疾病风险研究

Scientific title:

Study on the In-hospital Prevalence Characteristics of Metabolic Syndrome and Associated Disease Risks

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:

陈姝 

研究负责人:

陈姝 

Applicant:

Chen Shu 

Study leader:

Chen Shu 

申请注册联系人电话:

Applicant telephone:

+86 18782580952

研究负责人电话:

Study leader's
telephone:

+86 825 2292597

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:

530771020@qq.com

研究负责人电子邮件:

Study leader's E-mail:

530771020@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:

四川省遂宁市船山区德胜西路127号

研究负责人通讯地址:

四川省遂宁市船山区德胜西路127号

Applicant address:

No.127, West Desheng Rd., Chuanshan District, Suining, Sichuan Province, China

Study leader's address:

No.127, West Desheng Rd., Chuanshan District, Suining, Sichuan Province, 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:

遂宁市中心医院

Applicant's institution:

Suining Central Hospital

研究负责人所在单位:

遂宁市中心医院

Affiliation of the Leader:

Suining Central Hospital

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

KYLLKS20260044

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:

遂宁市中心医院医学科研伦理委员会

Name of the ethic committee:

Medical Researsh Ethics Committee of Suining Central Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2026-02-13 00:00:00

伦理委员会联系人:

王曼

Contact Name of the ethic committee:

Man Wang

伦理委员会联系地址:

四川省遂宁市船山区德胜西路127号

Contact Address of the ethic committee:

No.127, West Desheng Rd., Chuanshan District, Suining, Sichuan Province, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 825 2292068

伦理委员会联系人邮箱:

Contact email of the ethic committee:

1063209851@qq.com

研究实施负责(组长)单位:

遂宁市中心医院

Primary sponsor:

Suining Central Hospital

研究实施负责(组长)单位地址:

四川省遂宁市船山区德胜西路127号

Primary sponsor's address:

No.127, West Desheng Rd., Chuanshan District, Suining, Sichuan Province, 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):

四川省

市(区县):

Country:

China

Province:

Sichuan

City:

单位(医院):

遂宁市中心医院

具体地址:

四川省遂宁市船山区德胜西路127号

Institution
hospital:

Suining Central Hospital

Address:

No.127, West Desheng Rd., Chuanshan District, Suining, Sichuan Province, China

经费或物资来源:

自选课题(自筹)

Source(s) of funding:

self-financed

研究疾病:

代谢综合征  

Target disease:

Metabolic syndrome

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:

其它 

Study phase:

N/A

研究设计:

连续入组 

Study design:

Sequential 

研究目的:

1.明确住院患者MetS的总体及不同年龄、性别、科室亚组的流行特征; 2.识别MetS高风险科室,阐明其患者代谢及炎症指标的特征差异; 3.验证TyG指数对MetS的预测价值,明确其识别高危患者的潜力。  

Objectives of Study:

1. Clarify the overall prevalence characteristics of MetS in inpatients and its subgroup prevalence characteristics by different ages, genders, and departments; 2. Identify departments with a high risk of MetS, and clarify the characteristic differences in metabolic and inflammatory indicators among their patients; 3. Verify the diagnostic value of the TyG index for MetS, and clarify its potential in identifying high-risk patients.

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.年龄≥18周岁。 2.住院患者:首次入院记录完整; 3.体检人群:完成标准成人健康体检套餐。 4.病历或体检报告中完整记录腰围、血压、空腹血糖、甘油三酯、高密度脂蛋白胆固醇等MetS诊断必需指标。

Inclusion criteria

1. Age >= 18 years old. 2. Inpatients: complete first admission records; 3. Physical examination population: completed the standard adult health check-up package. 4. Medical records or physical examination reports shall completely record the necessary indicators for MetS diagnosis, such as waist circumference, blood pressure, fasting blood glucose, triglycerides, and high-density lipoprotein cholesterol.

排除标准:

1.病历信息严重缺失,无法进行MetS诊断者。 2.妊娠期或哺乳期妇女。 3.因急性创伤、中毒等单一急症入院,且无任何慢性代谢性疾病记录者。

Exclusion criteria:

1. Those with severely missing medical record information, making it impossible to diagnose MetS. 2. Pregnant or lactating women. 3. Those admitted due to a single acute condition such as acute trauma or poisoning, with no records of any chronic metabolic diseases.

研究实施时间:

Study execute time:

From 2026-02-28 00:00:00 To 2028-12-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-02-28 00:00:00 To 2028-12-31 00:00:00

干预措施:

Interventions:

组别:

建模队列组 / 验证队列组

样本量:

2000

Group:

Modeling Queue Group / Validation Queue 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):

四川省 

市(区县):

 

Country:

China

Province:

Sichuan

City:

单位(医院):

遂宁市中心医院 

单位级别:

三级甲等 

Institution
hospital:

Suining Central Hospital

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

甘油三酯葡萄糖指数(TyG 指数)对代谢综合征的预测效能

指标类型:

主要指标

Outcome:

The predictive efficacy of the Triglyceride-Glucose Index (TyG Index) for metabolic syndrome

Type:

Primary indicator

测量时间点:

测量方法:

空腹采血检测血糖、甘油三酯,计算 TyG 指数,ROC 曲线分析

Measure time point of outcome:

Measure method:

Fasting blood sampling to detect blood glucose and triglycerides, calculate the TyG index, and perform ROC curve analysis

指标中文名:

灵敏度

指标类型:

主要指标

Outcome:

Sensitivity

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

特异度

指标类型:

主要指标

Outcome:

Specificity

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:

组织:

Sample Name:

NA

Tissue:

人体标本去向

其它  

说明

Fate of sample:

0thers  

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 18 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):

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法:

Blinding:

None

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):

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

None

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(Case Record Form, CRF); 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:

Case Record Form, CRF;Electronic Data Capture, ED

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2026-02-27 10:32:30