中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2600127184
最近更新日期： Date of Last Refreshed on：	2026-06-26 10:30:11
注册时间： Date of Registration：	2026-06-26 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	H3K14la乳酸化修饰水平与糖尿病肾病临床表型相关性的前瞻性横断面观察性研究
Public title：	A Prospective Cross-sectional Observational Study on the Association Between H3K14la Levels and Clinical Phenotypes of Diabetic Kidney Disease
注册题目简写：
English Acronym：
研究课题的正式科学名称：	H3K14la乳酸化修饰在糖尿病肾病中的作用及其ELISA试剂盒开发
Scientific title：	The Role of H3K14la in Diabetic Kidney Disease and the Development of an ELISA Kit
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：	乔博洋	研究负责人：	乔博洋
Applicant：	Boyang Qiao	Study leader：	Boyang Qiao
申请注册联系人电话： Applicant telephone：	+86 477 859 0623	研究负责人电话： Study leader's telephone：	+86 477 859 0623
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：	2020203060050@whu.edu.cn	研究负责人电子邮件： Study leader's E-mail：	2020203060050@whu.edu.cn
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：	内蒙古鄂尔多斯市康巴什区苏都街6号	研究负责人通讯地址：	鄂尔多斯市东胜区伊金霍洛西街23号（康巴什部：康巴什新区苏都街6号）
Applicant address：	No. 6, Sudu Street, Kangbashi District, Ordos City, Inner Mongolia Autonomous Region, China, 017000	Study leader's address：	No. 23, Ejin Horo West Street, Dongsheng District, Ordos(Kangbashi branch: No. 6, Sudu Street, Kangbashi New Area)
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：	鄂尔多斯市中心医院
Applicant's institution：	Ordos Central Hospital
研究负责人所在单位：	鄂尔多斯市中心医院
Affiliation of the Leader：	Ordos Central Hospital

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：	2026-119	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：	鄂尔多斯市中心医院伦理委员会
Name of the ethic committee：	Ordos Central Hospital Ethics Committee
伦理委员会批准日期： Date of approved by ethic committee：	2026-06-01 00:00:00
伦理委员会联系人：	肖斌
Contact Name of the ethic committee：	xiaobin
伦理委员会联系地址：	鄂尔多斯市东胜区伊金霍洛西街23号（康巴什部：康巴什新区苏都街6号）
Contact Address of the ethic committee：	No. 23, Ejin Horo West Street, Dongsheng District, Ordos(Kangbashi branch: No. 6, Sudu Street, Kangbashi New Area)
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 477 8367226	伦理委员会联系人邮箱： Contact email of the ethic committee：	524069120@qq.com

研究实施负责（组长）单位：

鄂尔多斯市中心医院

Primary sponsor：

Ordos Central Hospital

研究实施负责（组长）单位地址：

鄂尔多斯市东胜区伊金霍洛西街23号（康巴什部：康巴什新区苏都街6号）

Primary sponsor's address：

No. 23, Ejin Horo West Street, Dongsheng District, Ordos(Kangbashi branch: No. 6, Sudu Street, Kangbashi New Area)

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	内蒙古自治区	市(区县)：
Country：	China	Province：	Inner Mongolia Autonomous Region	City：
单位(医院)：	鄂尔多斯市中心医院	具体地址：	鄂尔多斯市东胜区伊金霍洛西街23号（康巴什部：康巴什新区苏都街6号）
Institution hospital：	Ordos Central Hospital	Address：	No. 23, Ejin Horo West Street, Dongsheng District, Ordos(Kangbashi branch: No. 6, Sudu Street, Kangbashi New Area)

经费或物资来源：

鄂尔多斯市青年科技人才支持项目（2025年度）

Source(s) of funding：

Ordos Young Scientific and Technological Talents Support Program (2025)

研究疾病：

糖尿病肾病

Target disease：

Diabetic Kidney Disease

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：

析因分组（即根据危险因素或暴露因素分组）

Study design：

Factorial

研究目的：

本研究拟前瞻性收集糖尿病肾病患者及健康对照者外周血样本和相关临床资料，检测外周血/PBMC中H3K14la乳酸化修饰水平，并结合血液转录组测序及生物信息学分析，探索H3K14la水平及其相关分子特征与糖尿病肾病患者eGFR、UACR等临床指标及疾病严重程度之间的关系，为阐明H3K14la在糖尿病肾病发生发展中的潜在作用及后续ELISA检测方法开发提供临床样本依据和前期研究基础。

Objectives of Study：

This study aims to prospectively collect peripheral blood samples and relevant clinical data from patients with diabetic kidney disease and healthy controls, measure H3K14la levels in peripheral blood/peripheral blood mononuclear cells, and investigate the associations between H3K14la-related molecular features and clinical indicators, including eGFR and UACR, as well as disease severity in patients with diabetic kidney disease, through transcriptome sequencing and bioinformatics analysis. This study will provide clinical sample-based evidence for clarifying the potential role of H3K14la in diabetic kidney disease and for the subsequent development of an ELISA-based detection method.

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

Diabetic kidney disease group 
1. Participants aged 18–90 years, with no restriction on sex.
2. Previously diagnosed with type 2 diabetes mellitus, or diagnosed with type 2 diabetes mellitus during routine clinical care.
3. Diagnosed with diabetic kidney disease or diabetes-related chronic kidney impairment based on clinical diagnosis, eGFR, UACR, and other relevant examinations.
4. Able to cooperate with peripheral blood collection, urine sample collection, and relevant clinical data collection.
5. Voluntarily agree to participate in this study and sign the informed consent form.

Healthy control group 
1.Participants aged 18–90 years, with no restriction on sex.
2. No history of diabetes mellitus, chronic kidney disease, or other definite serious chronic diseases.
3. No recent acute infection, fever, severe trauma, or major surgery.
4. Able to cooperate with peripheral blood collection, urine sample collection, and basic information collection.
5. Serum creatinine/eGFR at enrollment does not indicate obvious renal dysfunction,  UACR does not indicate obvious albuminuria, and HbA1c does not indicate obvious glucose metabolism abnormality.  .
6. Voluntarily agree to participate in this study and sign the informed consent form.

排除标准：

糖尿病肾病组排除标准 1.合并急性感染、严重创伤、近期重大手术或明显急性炎症状态； 2.合并其他明确原因导致的肾脏疾病，如原发性肾小球肾炎、狼疮性肾炎、ANCA相关性血管炎、梗阻性肾病、多囊肾等； 3.合并恶性肿瘤、严重肝功能不全、严重心功能不全或其他严重系统性疾病，研究者判断不适合入组； 4.近期接受可能显著影响免疫炎症状态或组蛋白修饰水平的特殊治疗，如大剂量糖皮质激素、免疫抑制剂或抗肿瘤治疗等； 5.妊娠或哺乳期女性； 6.采血困难或存在明显出血风险，研究者判断不适合采集外周血； 7.研究者认为不适合参加本研究的其他情况；健康对照组排除标准 1.既往诊断为糖尿病、慢性肾脏病、自身免疫性疾病、恶性肿瘤或严重心、肝、肾等系统疾病； 2.近期存在急性感染、发热、创伤、手术或明显炎症状态； 3.近期使用大剂量糖皮质激素、免疫抑制剂或其他可能显著影响免疫炎症状态的药物； 4.入组时血肌酐/eGFR提示明显肾功能异常，或UACR提示明显白蛋白尿； 5.HbA1c提示明显糖代谢异常，或研究者根据病史及检查结果判断不符合健康对照要求； 6.妊娠或哺乳期女性； 7.采血困难或存在明显出血风险； 8.研究者认为不适合参加本研究的其他情况；

Exclusion criteria：

Diabetic kidney disease group 1. Patients with acute infection, severe trauma, recent major surgery, or an obvious acute inflammatory condition. 2. Patients with kidney diseases caused by other definite etiologies, such as primary glomerulonephritis, lupus nephritis, ANCA-associated vasculitis, obstructive nephropathy, polycystic kidney disease, etc. 3. Patients with malignant tumors, severe hepatic insufficiency, severe cardiac insufficiency, or other severe systemic diseases who are considered by the investigator to be unsuitable for enrollment. 4. Patients who have recently received special treatments that may significantly affect immune-inflammatory status or histone modification levels, such as high-dose glucocorticoids, immunosuppressive agents, or anti-tumor therapy. 5. Pregnant or lactating women. 6. Patients with difficulty in blood collection or an obvious risk of bleeding who are considered by the investigator to be unsuitable for peripheral blood collection. 7. Other conditions considered by the investigator to be unsuitable for participation in this study. Healthy control group 1. Previous diagnosis of diabetes mellitus, chronic kidney disease, autoimmune disease, malignant tumor, or severe cardiac, hepatic, renal, or other systemic diseases. 2. Recent acute infection, fever, trauma, surgery, or obvious inflammatory condition. 3. Recent use of high-dose glucocorticoids, immunosuppressive agents, or other medications that may significantly affect immune-inflammatory status. 4. Serum creatinine/eGFR at enrollment indicates obvious renal dysfunction, or UACR indicates obvious albuminuria. 5. HbA1c indicates obvious glucose metabolism abnormality, or the investigator determines that the participant does not meet the requirements for healthy controls based on medical history and examination results. 6. Pregnant or lactating women. 7. Difficulty in blood collection or an obvious risk of bleeding. 8. Other conditions considered by the investigator to be unsuitable for participation in this study.

研究实施时间：

Study execute time：

从 From 2026-07-01 00:00:00至 To 2028-05-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-07-01 00:00:00 至 To 2027-06-30 00:00:00

干预措施：

Interventions：

组别：	健康对照组	样本量：	20
Group：	Healthy control group	Sample size：	20
干预措施：	健康状态	干预措施代码：
Intervention：	Healthy status without diabetes or kidney disease	Intervention code：

组别：	糖尿病肾病组	样本量：	60
Group：	Diabetic kidney disease group	Sample size：	60
干预措施：	糖尿病肾病状态	干预措施代码：
Intervention：	Presence of diabetic kidney disease	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	内蒙古自治区	市(区县)：
Country：	China	Province：	Inner Mongolia Autonomous Region	City：
单位(医院)：	鄂尔多斯市中心医院	单位级别：	三级甲等
Institution hospital：	Ordos Central Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	血肌酐、eGFR、UACR、HbA1c	指标类型：	次要指标
Outcome：	Blood creatinine, eGFR, UACR, HbA1c	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	血液/PBMC转录组相关分子特征	指标类型：	次要指标
Outcome：	Blood/PBMC transcriptome-related molecular features	Type：	Secondary indicator
测量时间点：		测量方法：	采用RNA-seq检测血液/PBMC样本转录组特征，并进行差异表达分析、共表达网络分析和功能富集分析
Measure time point of outcome：		Measure method：	RNA sequencing will be performed on blood/PBMC samples, followed by differential expression analysis, co-expression network analysis, and functional enrichment analysis.

指标中文名：	PBMC中H3K14la乳酸化修饰水平	指标类型：	主要指标
Outcome：	H3K14la lactylation level in PBMCs	Type：	Primary indicator
测量时间点：		测量方法：	采集受试者基线外周血，分离外周血单个核细胞，采用Western blot检测PBMC中H3K14la水平，并以total H3作为归一化参考
Measure time point of outcome：		Measure method：	PBMC will be isolated from baseline blood samples.Western blot was used to detect the level of H3K14la in PBMCs and total H3 was used as a normalization reference.

采集人体标本：

Collecting sample(s)
from participants：

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
Fate of sample：	Preservation 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	18	岁 years
最大 Max age	90	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）：

无

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：	无
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）：	本研究不计划公开共享可识别个人身份的原始个体数据。研究结果发表时，可根据期刊要求、伦理审批意见及医院数据管理规定，提供去标识化后的汇总数据、统计分析结果或必要的补充材料。涉及RNA-seq等组学数据时，如期刊或数据库有要求，将在去除可识别个人身份信息后，按伦理委员会和医院数据管理要求进行提交或共享。研究者如需使用去标识化数据，可在合理申请并经研究团队、医院及伦理委员会审核同意后获得有限访问权限。
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Individual participant data with identifiable personal information will not be publicly shared. After publication, de-identified aggregate data, statistical results, or necessary supplementary materials may be provided according to journal requirements, ethics approval, and institutional data management policies. For omics data such as RNA-seq data, if required by journals or public databases, data will be submitted or shared after removal of identifiable personal information and in accordance with the requirements of the ethics committee and institutional data management policies. Access to de-identified data may be granted upon reasonable request and approval by the research team, institution, and ethics committee.
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：	本研究采用统一病例报告表（CRF）和电子表格/电子数据库进行数据采集和管理。研究人员为每位受试者分配唯一研究编号，采集一般资料、临床检验指标、样本处理记录、H3K14la检测结果及RNA-seq相关分析结果。纸质资料由专人保存在上锁文件柜中，电子数据保存在设有访问权限的电脑或医院认可的数据存储介质中，并定期备份。研究数据库不直接记录姓名、身份证号、联系电话等可识别个人身份的信息。数据录入后由研究负责人或指定人员进行核对，确保数据真实、完整、准确和可追溯。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Data will be collected and managed using a standardized case report form (CRF) and electronic spreadsheets or databases. Each participant will be assigned a unique study identification number. Collected data will include demographic information, clinical laboratory indicators, sample processing records, H3K14la measurement results, and RNA-seq-related analysis results. Paper records will be stored in locked cabinets by designated personnel, and electronic data will be stored on password-protected computers or institution-approved storage devices with regular backup. The study database will not directly contain identifiable personal information such as names, identification numbers, or telephone numbers. Data entry will be checked by the principal investigator or designated personnel to ensure accuracy, completeness, authenticity, and traceability.
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2026-06-26 10:29:14