PGAM1 介导的滑膜巨噬细胞糖酵解代谢在骨关节炎中的致病机制研究

注册号:

Registration number:

ChiCTR2600118012 

最近更新日期:

Date of Last Refreshed on:

2026-01-30 18:14:18 

注册时间:

Date of Registration:

2026-01-30 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

PGAM1 介导的滑膜巨噬细胞糖酵解代谢在骨关节炎中的致病机制研究

Public title:

Study on the Pathogenic Mechanism of PGAM1 in Osteoarthritis

注册题目简写:

PGAM1 在骨关节炎中的致病机制研究

English Acronym:

Study on the Pathogenic Mechanism of PGAM1-Mediated Glycolytic Metabolism in Synovial Macrophages during Osteoarthritis

研究课题的正式科学名称:

PGAM1 介导的滑膜巨噬细胞糖酵解代谢在骨关节炎中的致病机制研究

Scientific title:

Study on the Pathogenic Mechanism of PGAM1-Mediated Glycolytic Metabolism in Synovial Macrophages during Osteoarthritis

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:

洪海南 

研究负责人:

洪海南 

Applicant:

Hainan Hong 

Study leader:

Hainan Hong 

申请注册联系人电话:

Applicant telephone:

+86 137 7767 4937

研究负责人电话:

Study leader's
telephone:

+86 576 8512 0120

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:

honghn@enzemed.com

研究负责人电子邮件:

Study leader's E-mail:

honghn@enzemed.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:

浙江省台州市临海市西门街150号

研究负责人通讯地址:

浙江省台州市临海西门街150号

Applicant address:

150 Ximen Street, Linhai City, Taizhou City, Zhejiang Province, P.R. China

Study leader's address:

150 Linhai Ximen Street, Taizhou City, Zhejiang 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:

浙江省台州医院

Applicant's institution:

Taizhou Hospital, Zhejiang Province

研究负责人所在单位:

浙江省台州医院

Affiliation of the Leader:

TAIZHOU HOSPITAL OF ZHEJIANG PROVINCE

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:

K20260148

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:

浙江省台州医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of Taizhou Hospital in Zhejiang Province

伦理委员会批准日期:

Date of approved by ethic committee:

2026-01-26 00:00:00

伦理委员会联系人:

叶凌凌

Contact Name of the ethic committee:

Ye LingLing

伦理委员会联系地址:

浙江省台州市临海西门街150号

Contact Address of the ethic committee:

150 Linhai Ximen Street, Taizhou City, Zhejiang Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 576 8519 9615

伦理委员会联系人邮箱:

Contact email of the ethic committee:

yell@enzemed.com

研究实施负责(组长)单位:

浙江省台州医院

Primary sponsor:

TAIZHOU HOSPITAL OF ZHEJIANG PROVINCE

研究实施负责(组长)单位地址:

浙江省台州市临海西门街150号

Primary sponsor's address:

150 Linhai Ximen Street, Taizhou City, Zhejiang 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):

浙江省

市(区县):

Country:

China

Province:

Zhejiang

City:

单位(医院):

浙江省台州医院

具体地址:

浙江省台州市临海西门街150号

Institution
hospital:

TAIZHOU HOSPITAL OF ZHEJIANG PROVINCE

Address:

150 Linhai Ximen Street, Taizhou City, Zhejiang Province

经费或物资来源:

自选课题(自筹)

Source(s) of funding:

Self-funded

研究疾病:

膝骨关节炎  

Target disease:

Osteoarthritis, OA

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:

队列研究 

Study design:

Cohort study 

研究目的:

阐明滑膜巨噬细胞中 PGAM1 在骨关节炎发病中的功能及作用机制,并验证通过靶向敲低 PGAM1 来干预 OA 的可行性  

Objectives of Study:

clarify the functions and underlying mechanisms of PGAM1 in synovial macrophages during the pathogenesis of osteoarthritis, and to verify the feasibility of intervening in OA via targeted knockdown of PGAM1.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

1.系统性免疫或感染性疾病史;

Exclusion criteria:

1.History of systemic immune or infectious diseases;

研究实施时间:

Study execute time:

From 2026-01-01 00:00:00 To 2028-12-30 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-01-30 00:00:00 To 2028-12-30 00:00:00

干预措施:

Interventions:

组别:

健康对照组

样本量:

10

Group:

Healthy Control Group

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

组别:

OA 组

样本量:

10

Group:

OA 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):

浙江省 

市(区县):

 

Country:

China

Province:

Zhejiang

City:

单位(医院):

浙江省台州医院 

单位级别:

三级甲等 

Institution
hospital:

TAIZHOU HOSPITAL OF ZHEJIANG PROVINCE

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

PGAM1靶向干预对骨关节炎进程的影响

指标类型:

主要指标

Outcome:

The Effect of Targeted Intervention on PGAM1 on the Progression of Osteoarthritis

Type:

Primary indicator

测量时间点:

实验开始时

测量方法:

Safranin O-Fast Green 染色和 OARSI 评分系统评估软骨退变程度,HE 染色观察滑膜增生与细胞浸润程度

Measure time point of outcome:

At the start of the experiment

Measure method:

Safranin O-Fast Green staining and the OARSI scoring system were used to evaluate the degree of cartilage degeneration, while Hematoxylin-Eosin (H&E) staining was performed to observe the extent of synovial hyperplasia and cellular infiltration.

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

None

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 50 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):

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

是Yes

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):

网上共享

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

share online

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:

CRF

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2026-01-30 18:14:10