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审核状态: Project audit state: |
通过审核 Successful |
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注册号: Registration number: |
ChiCTR2500103802 |
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最近更新日期: Date of Last Refreshed on: |
2025-06-05 16:09:14 |
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注册时间: Date of Registration: |
2025-06-05 00:00:00 |
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注册号状态: |
预注册 |
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Registration Status: |
Prospective registration |
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注册题目: |
2型糖尿病患者代谢相关脂肪性肝病患病率筛查 |
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Public title: |
Prevalence of Type 2 Diabetes in Patients with Metabolic Dysfunction-Associated Fatty Liver Disease |
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注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
2型糖尿病患者代谢相关脂肪性肝病患病率筛查 |
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Scientific title: |
Prevalence of Type 2 Diabetes in Patients with Metabolic Dysfunction-Associated Fatty Liver Disease |
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研究课题代号(代码): Study subject ID: |
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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: |
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申请注册联系人: |
夏明锋 |
研究负责人: |
高鑫 |
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Applicant: |
Xia Mingfeng |
Study leader: |
Xin Gao |
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申请注册联系人电话: Applicant telephone: |
+86 13611826871 |
研究负责人电话:
Study leader's |
+86 21 64041990 |
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申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
xia.mingfeng@zs-hospital.sh.cn |
研究负责人电子邮件: Study leader's E-mail: |
Happy20061208@126.com |
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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): |
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申请注册联系人通讯地址: |
上海市徐汇区枫林路180号 |
研究负责人通讯地址: |
上海市徐汇区枫林路180号五号楼509室 |
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Applicant address: |
No.180 Fenglin Road ,Xuhui District,Shanghai |
Study leader's address: |
Room 509,Building 5#.No.180 Fenglin Road ,Xuhui District,Shanghai |
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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: |
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申请人所在单位: |
复旦大学附属中山医院 |
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Applicant's institution: |
Zhongshan Hospital Fudan University |
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研究负责人所在单位: |
复旦大学附属中山医院 |
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Affiliation of the Leader: |
Zhongshan Hospital, Fudan University |
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是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
B2024-563 |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
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批准本研究的伦理委员会名称: |
复旦大学附属中山医院医学伦理委员会分委会二 |
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Name of the ethic committee: |
Ethics Committee of Zhongshan Hospital Fudan University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2024-12-26 00:00:00 | ||
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伦理委员会联系人: |
杨梦婕 |
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Contact Name of the ethic committee: |
Yang MengJie |
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伦理委员会联系地址: |
上海市徐汇区枫林路180号 |
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Contact Address of the ethic committee: |
No.180 Fenglin Road ,Xuhui District,Shanghai |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 21 31587871 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
yang.mengjie@zs-hospital.sh.cn |
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研究实施负责(组长)单位: |
复旦大学附属中山医院 |
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Primary sponsor: |
Zhongshan Hospital, Fudan University |
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研究实施负责(组长)单位地址: |
上海市徐汇区枫林路180号 |
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Primary sponsor's address: |
No.180 Fenglin Road ,Xuhui District,Shanghai |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
自筹 |
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Source(s) of funding: |
Self-funded |
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研究疾病: |
2型糖尿病,代谢相关性脂肪性肝病 |
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Target disease: |
Type 2 Diabetes, MASLD |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
观察性研究 |
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Study type: |
Observational study |
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研究所处阶段: |
其它 | ||||||||||||||||||||||
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Study phase: |
N/A |
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研究设计: |
横断面 |
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Study design: |
Cross-sectional |
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研究目的: |
本研究拟在2型糖尿病患者中进行MAFLD疾病的筛查,明确我国2型糖尿病患者MAFLD患病率及严重程度以及相关因素分析。 |
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Objectives of Study: |
This study aimed to screen MASLD in patients with type 2 diabetes and investigate the prevalence, severity and related risk factors of MASLD in patients with type 2 diabetes. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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纳入标准: |
1.年龄>=18周岁; |
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Inclusion criteria |
1.Adults aged > = 18 years old; 2.Diagnosis of type 2 diabetes by WHO criteria; 3.Voluntarily participate in the project. |
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排除标准: |
1型糖尿病或其他特殊类型糖尿病者; |
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Exclusion criteria: |
1.Type 1 diabetes or other types of diabetes; 2.Diabetic ketoacidosis, hyperglycemic hyperosmolar state, lactic acidosis. |
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研究实施时间: Study execute time: |
从 From 2025-01-21 00:00:00至 To 2027-01-21 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2025-06-10 00:00:00 至 To 2027-01-21 00:00:00 |
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干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
尚未开始 Not yet recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
无 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
N/A |
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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 |
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盲法: |
无 |
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Blinding: |
None |
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是否共享原始数据: IPD sharing |
否No |
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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): |
无 |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
None |
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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: |
采用电子化CRF和EDC系统 |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
We will use electronic CRF forms and EDC system. |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
无/No |