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：	ChiCTR2300067254
最近更新日期： Date of Last Refreshed on：	2023-05-12 20:20:39
注册时间： Date of Registration：	2023-01-01 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	糖尿病患者长期新冠肺炎的流行情况、中医证型及发病机制研究
Public title：	Investigation about the Prevalence, Chinese Medicine Syndrome Types and its Underlying Mechanism of Long COVID among Diabetic Patients
注册题目简写：
English Acronym：
研究课题的正式科学名称：	糖尿病患者长期新冠肺炎的流行情况、中医证型及发病机制研究
Scientific title：	Investigation about the Prevalence, Chinese Medicine Syndrome Types and its Underlying Mechanism of Long COVID among Diabetic Patients
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：	Wong Hoi Ki	研究负责人：	Bian Zhaoxiang
Applicant：	Wong Hoi Ki	Study leader：	Bian Zhaoxiang
申请注册联系人电话： Applicant telephone：	+86 19896541996	研究负责人电话： Study leader's telephone：	+852 34112905
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：	kkihwong@163.com	研究负责人电子邮件： Study leader's E-mail：	bianzxiang@gmail.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：	香港九龙九龙塘香港浸会大学浸会大学道7号	研究负责人通讯地址：	香港九龙九龙塘香港浸会大学浸会大学道7号
Applicant address：	Room 307, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Hong Kong Baptist University, Kowloon Tong, Kowloon, Hong Kong	Study leader's address：	Room 307, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Hong Kong Baptist University, Kowloon Tong, Kowloon, Hong Kong
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：	香港浸会大学中医学院
Applicant's institution：	School of Chinese Medicine, Hong Kong Baptist University
研究负责人所在单位：	香港浸会大学中医学院
Affiliation of the Leader：	School of Chinese Medicine, Hong Kong Baptist University

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：	REC/22-23/0220	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：	香港浸会大学伦理委员会
Name of the ethic committee：	Research Ethics Committee, Hong Kong Baptist University
伦理委员会批准日期： Date of approved by ethic committee：	2022-12-23 00:00:00
伦理委员会联系人：	Dr Cheung, King-Ho
Contact Name of the ethic committee：	Dr Cheung, King-Ho
伦理委员会联系地址：	香港九龙塘香港浸会大学
Contact Address of the ethic committee：	Research Office, Hong Kong Baptist University, Kowloon Tong, Hong Kong
伦理委员会联系人电话： Contact phone of the ethic committee：		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：

香港浸会大学中医学院

Primary sponsor：

School of Chinese Medicine, Hong Kong Baptist University

研究实施负责（组长）单位地址：

香港九龙九龙塘香港浸会大学浸会大学道7号

Primary sponsor's address：

Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Hong Kong Baptist University, Kowloon Tong, Kowloon, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	香港	市(区县)：
Country：	China	Province：	Hong Kong	City：
单位(医院)：	香港浸会大学中医学院	具体地址：	九龙九龙塘香港浸会大学浸会大学道7号
Institution hospital：	School of Chinese Medicine, Hong Kong Baptist University	Address：	7 Baptist University Road, Hong Kong Baptist University, Kowloon Tong, Kowloon

经费或物资来源：

Chinese Medicine Development Fund of the Hong Kong Special Administrative Region Government (22B2/012A)

Source(s) of funding：

Chinese Medicine Development Fund of the Hong Kong Special Administrative Region Government (22B2/012A)

研究疾病：

糖尿病，长期新冠肺炎

Target disease：

Diabetes mellitus, long COVID

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：

1.比较糖尿病(DM)患者感染Omicron后与非糖尿病患者的长期冠状病毒感染率。 2.探讨DM患者感染Omicron后长期新冠肺炎的常见中医证候类型。 3.探讨糖尿病(DM)患者感染Omicron后，不同中医证型长期新冠肺炎与肠道菌群组成的关系。

Objectives of Study：

1. To determine the prevalence of long COVID in diabetes mellitus (DM) patients after Omicron infection, compared with non-diabetics. 2. To investigate the common traditional Chinese medicine (TCM) syndrome types of long COVID in DM patients after Omicron infection. 3. To characterize the relationship between different traditional Chinese medicine (TCM) syndrome types of long COVID and the gut microbiota composition in diabetes mellitus (DM) patients after Omicron infection.

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

1. Phase 1 Study:
(1)	Aged 18 years or above.
(2)	The first diagnosis of COVID-19 by PCR test/RAT dated between February 18, 2022 and May 6, 2022.
(3)	Non-diabetics before COVID-19 or DM patients diagnosed by physician(s) before COVID-19.
(4)	Fully understand what is involved in this study and give documented consent to participate in the study.
(5)	Able to understand and be able to follow written and oral instructions in Chinese.
2. Phase 2 Study:
(1)	Aged 18-65 years.
(2)	The latest diagnosis of COVID-19 by PCR test/RAT at least 4 weeks; and the latest test(s) had shown negative result(s) prior to the commencement of the study.
(3)	Non-diabetics before COVID-19 or DM patients diagnosed by physician(s) before COVID-19.
(4)	Meet the diagnostic criteria of long COVID: at least one new, returning, or ongoing health problem(s) experienced by people four or more weeks after the initial coronavirus infection.
(5)	Have experienced at least one long COVID symptom(s) within the past 7 days.
(6)	Verbally communicable.
(7)	Fully understand what is involved in this study and give documented consent to participate in the study.
(8)	Able to understand and be able to follow written and oral instructions in Chinese.
3. Phase 3 Study:
(1)	Aged 18-65 years. 
(2)	The latest diagnosis of COVID-19 by PCR test/RAT at least 4 weeks; and the latest test(s) had shown negative result(s) prior to the commencement of the study. 
(3)	Non-diabetics before COVID-19 or DM patients diagnosed by physician(s) before COVID-19.
(4)	Meet the diagnostic criteria of long COVID: at least one new, returning, or ongoing health problem(s) experienced by people four or more weeks after the initial coronavirus infection.
(5)	Have experienced at least one long COVID symptom(s) within the past 7 days.
(6)	Verbally communicable.
(7)	Have completed the 2nd phase (face-to-face TCM syndrome type diagnosis) of the study.
(8)	Falls into one of the five most common TCM syndrome types of long COVID with reference to the result(s) of the phase 2 study.
(9)	Fully understand what is involved in this study and give documented consent to participate in the study.
(10)	Able to understand and be able to follow written and oral instructions in Chinese.

排除标准：

1. 患有严重疾病的个人，如心/脑血管、呼吸、消化、肝脏、肾脏、血液系统疾病或其他器官和系统异常;恶性肿瘤、重大传染病或神经精神疾病。 2. 孕妇、哺乳期妇女以及怀疑怀孕的妇女。 3. 弱势成年人(即精神或身体残疾，不能照顾自己)。 4. 其他研究者或共同研究者认为不适合入组的人(必须提供合理的理由)。

Exclusion criteria：

1. With any serious commodities, such as cardio-/cerebro-vascular, respiratory, digestive, hepatic, renal, haematological disease(s) or abnormalities of other organs and systems; malignancies, major infectious disease(s) or neuropsychiatric disorders. 2. Pregnant and nursing subjects as well as those who are suspected of being pregnant. 3. Vulnerable adults (i.e. mentally or physically disabled who cannot take care of himself/herself). 4. Others whom the investigator or co-investigator considered to be inappropriate for enrolment (justifiable reason(s) must be provided).

研究实施时间：

Study execute time：

从 From 2023-01-01 00:00:00至 To 2023-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2023-01-01 00:00:00 至 To 2023-08-31 00:00:00

干预措施：

Interventions：

组别：	1期DM组	样本量：	575
Group：	Phase 1 DM group	Sample size：	575
干预措施：	无	干预措施代码：
Intervention：	None	Intervention code：

组别：	1期非DM组	样本量：	575
Group：	Phase 1 non-DM group	Sample size：	575
干预措施：	无	干预措施代码：
Intervention：	None	Intervention code：

组别：	2期DM组	样本量：	230
Group：	Phase 2 DM group	Sample size：	230
干预措施：	无	干预措施代码：
Intervention：	None	Intervention code：

组别：	2期非DM组	样本量：	230
Group：	Phase 2 non-DM group	Sample size：	230
干预措施：	无	干预措施代码：
Intervention：	None	Intervention code：

组别：	3期DM组	样本量：	115
Group：	Phase 3 DM group	Sample size：	115
干预措施：	无	干预措施代码：
Intervention：	None	Intervention code：

组别：	3期非DM组	样本量：	115
Group：	Phase 3 non-DM group	Sample size：	115
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)：	香港	市(区县)：
Country：	China	Province：	Hong Kong	City：
单位(医院)：	香港浸会大学陈汉贤伉俪中医专科诊所暨临床规范研究中心	单位级别：
Institution hospital：	Hong Kong Baptist University Mr. & Mrs. Chan Hon Yin Chinese Medicine Specialty Clinic and Good Clinical Practice Centre	Level of the institution：

测量指标：

Outcomes：

指标中文名：	糖尿病患者和非糖尿病患者感染COVID-19后长期新冠肺炎的发生	指标类型：	主要指标
Outcome：	Occurrence of long COVID in DM patients and non-diabetics post COVID-19	Type：	Primary indicator
测量时间点：	0周	测量方法：
Measure time point of outcome：	Week 0	Measure method：

指标中文名：	糖尿病患者和非糖尿病患者感染COVID-19后长期新冠肺炎的症状类型	指标类型：	次要指标
Outcome：	Symptom types of long COVID in DM patients and non-diabetics post COVID-19	Type：	Secondary indicator
测量时间点：	0周	测量方法：
Measure time point of outcome：	Week 0	Measure method：

指标中文名：	糖尿病患者和非糖尿病患者感染COVID-19后长期新冠肺炎的症状	指标类型：	次要指标
Outcome：	Symptoms of long COVID in DM patients and non-diabetics post COVID-19	Type：	Secondary indicator
测量时间点：	0周	测量方法：
Measure time point of outcome：	Week 0	Measure method：

指标中文名：	糖尿病患者和非糖尿病患者感染COVID-19后长期新冠肺炎的症状严重程度	指标类型：	次要指标
Outcome：	Symptom severities of long COVID in DM patients and non-diabetics post COVID-19	Type：	Secondary indicator
测量时间点：	0周	测量方法：
Measure time point of outcome：	Week 0	Measure method：

指标中文名：	患有长期新冠肺炎的糖尿病患者与非糖尿病患者的生活质量	指标类型：	次要指标
Outcome：	Quality of life of DM patients and non-diabetics with long COVID	Type：	Secondary indicator
测量时间点：	0周	测量方法：
Measure time point of outcome：	Week 0	Measure method：

指标中文名：	新冠肺炎后糖尿病患者与非糖尿病患者的中医证候分型	指标类型：	次要指标
Outcome：	TCM syndrome types of long COVID in DM patients and non-diabetics post COVID-19	Type：	Secondary indicator
测量时间点：	1周	测量方法：
Measure time point of outcome：	Week 1	Measure method：

指标中文名：	长期新冠肺炎的糖尿病患者和非糖尿病患者的肠道菌群结构	指标类型：	次要指标
Outcome：	Gut microbiota structure of DM patients and non-diabetics with long COVID	Type：	Secondary indicator
测量时间点：	2周	测量方法：
Measure time point of outcome：	Week 2	Measure method：

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	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

标本中文名：	粪便	组织：
Sample Name：	Stool	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

标本中文名：	尿液	组织：
Sample Name：	Urine	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	18	岁 years
最大 Max age	65	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）：

N/A, this is a 4-week observational study.

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

N/A, this is a 4-week observational study.

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：
Blinding：
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	We will use REDCap online system to store and share IPD data.
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	We will use REDCap online system to store and share IPD data.
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：	This is a 4-week observational study, in which subjects need to attend 1 online questionnaire, 1 assessment visit (face-to-face traditional Chinese medicine syndrome type investigation), provide 1 set of blood, stool, and urine sample. The blood test includes complete blood count (CBC), biochemistry test (renal function, liver function, electrolytes, etc.). The urinalysis includes visual exam (urine color and clarity), chemical exam (specific gravity, pH, bilirubin, urobilinogen, protein, glucose, ketones, hemoglobin and myoglobin, leukocyte esterase, nitrite, ascorbic acid), microscopic exam (red blood cells, white blood cells, epithelial cells, bacteria, yeast and parasites, casts, crystals). The stool analysis includes visual exam (color, consistency, amount, shape, odor, and the presence of mucus), microscopic examination, chemical tests, and microbiologic tests. All laboratory tests will be conducted in Hong Kong Chan & Hou Medical Laboratories Ltd. Original data of study forms will be entered and kept on file at the participating site on both paper and electronic version. We will use REDCap, a secure web application for building and managing online surveys and databases, to store our electronic data. PI and RAs will use electronic case report form (eCRF) to record patients' information during the whole study. All the files are to be stored in numerical order and stored in a secure and accessible place. Participant files will be maintained in storage for a period of 5 years. In order to maximize subjects' compliance, we first run a thorough consent process for all participants by explaining the details of the study schedule, potential risks of assessments, and the responsibilities that need to be undertaken by subjects. Second, support and reassurance are provided during the whole study. Third, we will carefully scrutinize subjects to exclude ineligible and potentially low compliance individuals before allocation. Fourth, a direct telephone hotline, email account and social media account are established in order to optimize active communication with patients and to respond to enquiries. Participants who are inclined to drop out of the study will be contacted by the research team to resolve any issues that may prevent them from completing the study. Overall participant compliance will be assessed by the successful completion of online questionnaires, face-to-face TCM syndrome type investigation as well as provision of biological samples. Those who fail to complete these tasks within the specified timeframe will be followed up. Study candidates and enrolled participants will provide their data electronically which will then be uploaded to REDCap without manual data transfer: 1) individuals who are interested in participating in this study will complete an online/telephone screening questionnaire. The data will be synchronized to REDCap; 2) study candidates and enrolled participants will complete the online questionnaire on REDCap using their smartphones or via telephone survey by members of the research team. Members of the research team who conduct telephone screening interviews, in-person screening visits and study visits will complete the e-CRF in REDCap in real time. Data from external sources, e.g. clinical laboratories, will be received in the form of reports. The data will be manually entered into REDCap. Microbiome sequencing data will be directly downloaded from the sequencer and uploaded to REDCap. Two individuals from the School of Chinese medicine with expertise in clinical research and are not directly involved in this study will monitor the overall conduct of the study. Specifically, they will review the study progress including recruitment, retention, adverse events and study outcomes. They will also assess adherence to the research protocol, including the completion of informed consent and assessment processes, accuracy of data documentation, and specimen and data storage.
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	This is a 4-week observational study, in which subjects need to attend 1 online questionnaire, 1 assessment visit (face-to-face traditional Chinese medicine syndrome type investigation), provide 1 set of blood, stool, and urine sample. The blood test includes complete blood count (CBC), biochemistry test (renal function, liver function, electrolytes, etc.). The urinalysis includes visual exam (urine color and clarity), chemical exam (specific gravity, pH, bilirubin, urobilinogen, protein, glucose, ketones, hemoglobin and myoglobin, leukocyte esterase, nitrite, ascorbic acid), microscopic exam (red blood cells, white blood cells, epithelial cells, bacteria, yeast and parasites, casts, crystals). The stool analysis includes visual exam (color, consistency, amount, shape, odor, and the presence of mucus), microscopic examination, chemical tests, and microbiologic tests. All laboratory tests will be conducted in Hong Kong Chan & Hou Medical Laboratories Ltd. Original data of study forms will be entered and kept on file at the participating site on both paper and electronic version. We will use REDCap, a secure web application for building and managing online surveys and databases, to store our electronic data. PI and RAs will use electronic case report form (eCRF) to record patients' information during the whole study. All the files are to be stored in numerical order and stored in a secure and accessible place. Participant files will be maintained in storage for a period of 5 years. In order to maximize subjects' compliance, we first run a thorough consent process for all participants by explaining the details of the study schedule, potential risks of assessments, and the responsibilities that need to be undertaken by subjects. Second, support and reassurance are provided during the whole study. Third, we will carefully scrutinize subjects to exclude ineligible and potentially low compliance individuals before allocation. Fourth, a direct telephone hotline, email account and social media account are established in order to optimize active communication with patients and to respond to enquiries. Participants who are inclined to drop out of the study will be contacted by the research team to resolve any issues that may prevent them from completing the study. Overall participant compliance will be assessed by the successful completion of online questionnaires, face-to-face TCM syndrome type investigation as well as provision of biological samples. Those who fail to complete these tasks within the specified timeframe will be followed up. Study candidates and enrolled participants will provide their data electronically which will then be uploaded to REDCap without manual data transfer: 1) individuals who are interested in participating in this study will complete an online/telephone screening questionnaire. The data will be synchronized to REDCap; 2) study candidates and enrolled participants will complete the online questionnaire on REDCap using their smartphones or via telephone survey by members of the research team. Members of the research team who conduct telephone screening interviews, in-person screening visits and study visits will complete the e-CRF in REDCap in real time. Data from external sources, e.g. clinical laboratories, will be received in the form of reports. The data will be manually entered into REDCap. Microbiome sequencing data will be directly downloaded from the sequencer and uploaded to REDCap. Two individuals from the School of Chinese medicine with expertise in clinical research and are not directly involved in this study will monitor the overall conduct of the study. Specifically, they will review the study progress including recruitment, retention, adverse events and study outcomes. They will also assess adherence to the research protocol, including the completion of informed consent and assessment processes, accuracy of data documentation, and specimen and data storage.
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2023-01-01 20:43:44