ChiCTR2600123055 版本V1.0 版本创建时间2026/04/21 10:54:36 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：

 ChiCTR2600123055 

最近更新日期：

Date of Last Refreshed on：

 2026-04-21 10:54:05 

注册时间：

Date of Registration：

 2026-04-21 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

以目标为导向的综合代谢预防模式（TCMP模式）对老年HIV感染者共病风险及衰老进程的影响：一项随机对照研究方案

Public title：

Evaluating the effect of a goal-oriented comprehensive metabolic prevention (TCMP) model on comorbid risk and aging trajectory in elderly individuals living with HIV:A randomized controlled trial

注册题目简写：

HIV感染人群衰老标志物及共病预防策略研究

English Acronym：

A Study on Biomarkers of Aging and Co-Comorbidity Prevention in People Living with HIV

研究课题的正式科学名称：

HIV感染人群衰老标志物及共病预防策略研究

Scientific title：

A Study on Biomarkers of Aging and Co-Comorbidity Prevention in People Living with HIV

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：

鲁雁秋 

研究负责人：

李桓 

Applicant：

Yanqiu Lu 

Study leader：

Huan Li 

申请注册联系人电话：

Applicant telephone：

 +86 136 5768 6269

研究负责人电话：

Study leader's
telephone：

+86 158 2597 3506

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：

 doctorlu828@163.com

研究负责人电子邮件：

Study leader's E-mail：

 huangyinqiu917@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：

重庆市沙坪坝区歌乐山镇109号

研究负责人通讯地址：

重庆市沙坪坝区歌乐山镇109号

Applicant address：

No. 109, Geleshan Town, Shapingba District, Chongqing

Study leader's address：

No. 109, Geleshan Town, Shapingba District, Chongqing

申请注册联系人邮政编码：

Applicant postcode：

 400036

研究负责人邮政编码：

Study leader's postcode：

 400036

申请人所在单位：

重庆市公共卫生医疗救治中心

Applicant's institution：

Chongqing Public Health Medical Center,

研究负责人所在单位：

重庆市公共卫生医疗救治中心

Affiliation of the Leader：

Chongqing Public Health Medical Center,

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：

 2025-048-02-KY

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：

重庆市公共卫生医疗救治中心伦理委员会

Name of the ethic committee：

Ethics Committee of Chongqing Public Health Medical Treatment Center

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-12-18 00:00:00

伦理委员会联系人：

李小方

Contact Name of the ethic committee：

Xiaofang Li

伦理委员会联系地址：

重庆市沙坪坝区歌乐山镇保育路109号

Contact Address of the ethic committee：

109 Baoyu Road, Geleshan Town, Shapingba District, Chongqing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 23 6551 8197

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：

重庆市公共卫生医疗救治中心

Primary sponsor：

Chongqing Public Health Medical Treatment Center

研究实施负责（组长）单位地址：

重庆市沙坪坝区歌乐山镇保育路109号

Primary sponsor's address：

109 Baoyu Road, Geleshan Town, Shapingba District, Chongqing, 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)：

重庆

市(区县)：

Country：

China

Province：

Chongqing

City：

单位(医院)：

重庆市公共卫生医疗救治中心

具体地址：

沙坪坝区歌乐山镇保育路109号

Institution
hospital：

Chongqing Public Health Medical Treatment Center

Address：

109 Baoyu Road, Geleshan Town, Shapingba District

经费或物资来源：

重庆市医学科研项目（卫生健康委员会和科技局联合）

Source(s) of funding：

Chongqing?medical?scientific?research?project?(Joint?project?of?Chongqing?Health?Commission?and?Science?and?Technology?Bureau)

研究疾病：

艾滋病  

Target disease：

HIV

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

基于前瞻性随机队列，评估TCMP模式对降低共病发生率和改善功能衰老指数（FAI）的有效性  

Objectives of Study：

Based on a prospective randomized cohort, the effectiveness of the TCMP model in reducing the incidence of comorbidity and improving the functional aging index (FAI) was evaluated

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>=50岁； 2. HIV感染者（依据《中国艾滋病诊疗指南（2024版）》确诊）； 3. CD4+>=200 cells/mm^3； 4. 未合并慢性躯体疾病（依据《老年人多病共存专家共识（2022）》）。

Inclusion criteria

1. Age >=50 years old; 2. HIV-infected individuals (diagnosed in accordance with the "Chinese AIDS Diagnosis and Treatment Guidelines (2024 Edition)"); 3. CD4+ >=200 cells/mm^3; 4. No concurrent chronic physical diseases (as per the "Expert Consensus on Coexistence of Multiple Diseases in the Elderly (2022)").

排除标准：

1. 合并活动性机会性感染，包括但不限于：CMV感染、隐球菌感染、艾滋相关肿瘤、结核、乙肝、丙肝等。 2. 进入研究前 12 个月内有活动性癌症。 3. 在研究开始前30天内使用特异性免疫抑制剂或免疫调节剂，包括但不限于他克莫司、西罗莫司、雷帕霉素、霉酚酸盐、环孢素、TNF-α阻断剂或拮抗剂、硫唑嘌呤、干扰素、生长因子或静脉注射免疫球蛋白（IVIG）。 4. 目前正在使用红霉素、秋水仙碱或利福平。 5. 已知的活动性或近期（入组前 30 天内未完全治愈）全身性细菌、真菌、寄生虫或病毒感染。

Exclusion criteria：

1. Concurrent active opportunistic infections, including but not limited to: CMV infection, cryptococcal infection, AIDS-related tumors, tuberculosis, hepatitis B, hepatitis C, etc. 2. Active cancer was present within 12 months prior to entering the study. 3. Specific immunosuppressants or immunomodulators, including but not limited to tacrolimus, sirolimus, rapamycin, mycophenolate mofetil, cyclosporine, TNF-α blockers or antagonists, azathioprine, interferon, growth factors or intravenous immunoglobulin (IVIG), should be used within 30 days prior to the start of the study. 4. Currently, erythromycin, colchicine or rifampicin are being used. 5. Known active or recent (not completely cured within 30 days before enrollment) systemic bacterial, fungal, parasitic or viral infections.

研究实施时间：

Study execute time：

从 From 2025-12-19 00:00:00至 To 2028-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-04-30 00:00:00 至 To 2028-12-31 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 200

Group：

Control Group

Sample size：

干预措施：

常规门诊随访， 每3个月监测HIV病毒载量、CD4+计数及基础代谢指标（如空腹血糖、 血压等） ， 按指南处理异常值。

干预措施代码：

Intervention：

Routine outpatient follow-up, monitoring HIV viral load, CD4 count, and basic metabolic indicators (such as fasting blood glucose, blood pressure, etc.) every 3 months, and managing abnormal values according to guidelines.

Intervention code：

组别：

TCMP模式组

样本量：

 200

Group：

TCMP Group

Sample size：

干预措施：

1. 目标值设定与动态管理： (1) 五大核心代谢目标：BMI（<25 kg/m^2）、HbA1c（<6.5%）、LDL-C（<2.6 mmol/L）、血压（<140/90 mmHg）、尿酸（<420 mmol/L）。 (2) 个体化目标矩阵：根据基线数据建立代谢风险矩阵，标注目标值与实际值差异，动态调整优先级。 2. 制定个性化干预策略：根据受试者基线的代谢矩阵，结合ASCVD风险分层，制定个性化干预策略，具体包括： (1) 低危+五大代谢指标均达标：达标维持，给予生活方式与运动方式指导，每3个月复评。 (2) 低危+1项未达标：强化生活方式干预（营养师定制膳食、运动处方）和依从性教育，观察3个月复评，根据复评结果调整方案。 (3) 低危+>=2项未达标或中危：启动药物强化（如加用二甲双胍、他汀类药物），进一步强化生活方式干预（营养师定制膳食、运动处方），并联合远程健康监测。

干预措施代码：

Intervention：

1. Target value setting and dynamic management: (1) Five core metabolic targets: BMI (< 25 kg/m^2), HbA1c (<6.5%), LDL-C (<2.6 mmol/L), blood pressure (<140/90 mmHg), uric acid (<420 mmol/L). (2) Individualized Target Matrix: Establish a metabolic risk matrix based on baseline data, mark the difference between target values and actual values, and dynamically adjust priorities. 2. Develop personalized intervention strategies: Based on the baseline metabolic matrix of the subjects and in combination with ASCVD risk stratification, develop personalized intervention strategies, specifically including: (1) Low-risk + all five metabolic indicators met the standards: maintained compliance, provided lifestyle and exercise guidance, and re-evaluated every three months. (2) Low-risk +1 item not met: Strengthen lifestyle intervention (nutritionist customized diet, exercise prescription) and compliance education. Observe for 3 months and re-evaluate. Adjust the plan based on the re-evaluation results. (3) Low-risk +>=2 items not met or medium-risk: Initiate drug intensification (such as adding metformin, statins), further enhance lifestyle intervention (nutritionist customized diet, exercise prescription), and combine with remote health monitoring.

Intervention code：

组别：

观察组 （横断面）

样本量：

 600

Group：

Observation group (Cross-section)

Sample size：

干预措施：

无

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)：

 重庆 

市(区县)：

  

Country：

China

Province：

Chongqing

City：

单位(医院)：

 重庆市公共卫生医疗救治中心 

单位级别：

 三级甲等 

Institution
hospital：

Chongqing Public Health Medical Treatment Center

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

代谢相关指标监测

指标类型：

主要指标

Outcome：

Monitoring of metabolism-related indicators

Type：

Primary indicator

测量时间点：

测量方法：

体重指数（BMI） 、 腰围、 臀围、 腰臀比、 血压； 血液检测 包括肝肾功、 血常规、 尿酸、 空腹血糖、 胰高血糖素、 糖化血红蛋白、 胰岛素、 血脂谱、 炎症因子（IL-6、 TNF-α 等）

Measure time point of outcome：

Measure method：

Body Mass Index (BMI), waist circumference, hip circumference, waist-to-hip ratio, blood pressure; blood tests including liver and kidney function, routine blood test, uric acid, fasting blood glucose, glucagon, glycated hemoglobin, insulin, lipid profile, inflammatory factors (IL-6, TNF-α, etc.)

指标中文名：

衰老指标监测

指标类型：

主要指标

Outcome：

Monitoring of aging indicators

Type：

Primary indicator

测量时间点：

测量方法：

免疫衰老： 流式细胞术检测CD8+、 CD4+/CD8+、 CD27+、 CD28+、CD45RA、 KLRG1和CD57+等。 血管衰老： 颈动脉内膜中层厚度（CIMT， 超声检查）、冠脉钙化积分（CAC， CT扫描） 。 神经认知功能： MoCA量表。 衰弱情况： 衰弱指数（Fried表型） 。

Measure time point of outcome：

Measure method：

Immune aging: Detection of CD8, CD4/CD8, CD27, CD28, CD45RA, KLRG1, and CD57 by flow cytometry. Vascular aging: Carotid intima-media thickness (CIMT, ultrasound) and coronary artery calcium score (CAC, CT scan). Neurocognitive function: MoCA scale. Frailty status: Frailty index (Fried phenotype).

指标中文名：

共病状态核查

指标类型：

次要指标

Outcome：

Verification of comorbidity status

Type：

Secondary indicator

测量时间点：

测量方法：

核查糖尿病、 高血压、 冠心病等疾病发生情况。

Measure time point of outcome：

Measure method：

Check the occurrence of diseases such as diabetes, hypertension, and coronary heart disease.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血浆

组织：

Sample Name：

Plasma

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 岁 years
最大 Max age 岁 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）：

采用区组随机化，由统计学家使用SAS软件生成随机化表（区组大小保密，以防止偏倚）

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

A block randomization scheme was employed, with the randomization schedule generated by a statistician using SAS software (block sizes were kept concealed to prevent bias).

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

无

Blinding：

None

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

试验完成后6个月内发表论文（请阅读网站首页注册指南共享原始数据的方式内容）

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

Publish papers within six months after the trial complete

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：

数据管理 本研究采用医研通数据平台进行电子化数据管理，在试验启动之前对参加人员进行相关培训。数据管理方根据病例报告表构建e-CRF。 1. 数据记录 (1) 研究者填写临床试验记录要求：及时、准确、完整、规范、真实； (2) 全部病例均按方案规定，认真书写病历和病例报告表，所有项目均需填写，不得空项、漏项（无记录的空格划斜线）； (3) 病历及病例报告表作为原始记录，做任何更正时只能划线，旁注修改后数据，说明理由并由参加临床试验的医师和研究者签名并注明日期，不得擦涂、覆盖原始记录； (4) 化验单齐全并粘贴在病例报告表上，病例报告表记录的数据要与病历及原始检验报告核对无误； (5) 对显著异常或在临床可接受范围以外的数据（实验室检查项目超过正常值的20%）需加以合适，由参加临床试验的医师做必要的说明； (6) 每一位受试者观察疗程结束后，研究者应在3个工作日内将病例报告表及病历交本单位主要研究者审核、签名。 2. 数据监察 (1) 主研单位质控人员在试验过程中要核查研究者是否遵循试验方案，定期去各试验中心检查受试者的知情同意及筛选纳入情况； (2) 确认所有病例报告表填写及时、正确，并与原始资料真实、一致；所有错误或遗漏均已改正或注明，经研究者签名并注明日期；每一受试者的剂量改变、治疗变更、合并用药、间发疾病、检查遗漏等均应确认并记录； (3) 核实入选受试者的退出须在病例报告表中予以说明；确认所有不良事件均应记录在案，严重不良事件在规定时间内作出报告并记录在案；核实试验用药品是否按照有关规定进行供应、储藏、分发、回收，并做相应的记录。 3. 数据保存 (1) 建立数据库：根据病例报告表的项目采用医研通数据平台建立相应录入程序，并设定录入时的逻辑审查限定条件，对数据库进行试运行，建立本试验专用的数据库系统； (2) 录入前再次核查：对病例报告表进一步检查。已经审核声明签字的病例报告表交数据管理员，数据管理员对日期、入组标准、排除标准、脱落、缺失值等进行检查，如有疑问，可填写疑问表返回检察员，由研究者对疑问表中的问题进行书面解答并签名，交回数据管理员，疑问表应妥善保管； (3) 数据录入：e-CRF数据来源于原始记录，由研究者根据e-CRF填写说明，将受试者研究数据及时录入医研通数据平台中，保证数据的真实、准确、完整、及时，并需确保与受试者原始病历数据核对一质性； (4) 数据审核：采用计算机软件中的核查功能进行逻辑检查与自动比较，查对与病例报告表不一致的结果值，然后逐项与原始病例报告表核对，予以更正。再进行病例报告表和数据库中的数据与病例报告表中的结果一致； (5) 数据锁定：由主要研究者、申办者，统计分析人员和数据管理人员共同签署数据锁定记录后，数据管理员进行数据库锁定。

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

Data Management In this study, the medical research and development data platform was used for electronic data management. The data management party builds an e-CRF based on the case report form and creates an account based on the information provided by the researcher. 1. Data Recording (1) The researcher fills in the clinical test record requirements: timely, accurate, complete, standardized, and true; (2) All cases are written according to the regulations, and the medical records and case report forms are carefully written. All items need to be filled out, with no empty items or missing items (spaces with no record are marked with a slash); (3) The medical record and case report form are used as the original records. Any corrections can only be crossed out, and the revised data should be inserted. The reasons are indicated and signed and dated by the doctors and researchers participating in the clinical trial; (4) The test list is complete and pasted on the case report form, and the data recorded in the case report form should be checked against the medical record and the original test report; (5) Significant abnormalities or data outside the clinically acceptable range (laboratory items exceeding 20% of the normal value) should be handled appropriately, and the necessary explanation should be given by the physician participating in the clinical trial; (6) After the end of the observation course, the investigator shall submit the case report form and the medical record to the main investigator of the unit for review and signature within 3 working days. 2. Data Monitoring (1) The quality control personnel of the main research unit should check whether the researcher follows the test plan during the test, and regularly go to each test center to check the subject's informed consent and screening and inclusion; (2) Confirm that all case report forms are filled in correctly and accurately, and are true and consistent with the original materials; all errors or omissions have been corrected or indicated, signed and dated by the investigator; dose changes, treatment changes, concomitant medications, intercurrent illnesses, and omissions for each subject should be confirmed and recorded; (3) Verification of the withdrawal of the selected subjects shall be stated in the case report form; confirmation that all adverse events shall be recorded, serious adverse events shall be reported and recorded within the specified time; verification of whether the test drugs are supplied, stored, distributed, and recycled in accordance with relevant regulations, and corresponding records shall be made. 3. Data Saving (1) Establish database: According to the items of the case report form, use the medical research data platform to establish the corresponding entry procedure, set the logical review qualification conditions at the time of entry, test run the database, and establish a database system dedicated to the test; (2) Check again before entry: further check the case report form. The case report form signed by the audited statement is submitted to the data administrator. The data manager checks the date, entry criteria, exclusion criteria, dropout, missing values, etc. If in doubt, a question form can be filled out and returned to the inspector. The questions in the question form are answered in writing and signed, and returned to the data administrator. The question form should be kept in a safe place; (3) Data entry: The e-CRF data is derived from the original record. The researcher fills in the e-CRF instructions and records the subject's research data into the medical research data platform in time to ensure the data is true, accurate, complete and timely. It is also necessary to ensure consistency with the subject's original medical record data through verification; (4) Data audit: Use the verification function in the computer software to perform logical checks and automatic comparisons, check the result values that are inconsistent with the case report form, and then check against the original case report form item by item and correct them. Ensure that the data in the database is consistent with the results in the case report form; (5) Data lock: After the data lock record is signed by the main researcher, sponsor, statistical analyst and data management personnel, the data administrator performs database lock.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-04-21 10:54:05