ChiCTR2300078372 版本V1.1 版本创建时间2024/08/10 14:32:30 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：

ChiCTR2300078372 

最近更新日期：

Date of Last Refreshed on：

2023-12-06 17:01:03 

注册时间：

Date of Registration：

2023-12-06 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

不同时段节点的高强度间歇运动对2型糖尿病患者糖脂代谢、胰岛β细胞功能、睡眠质量和运动自我效能的影响

Public title：

Effects of high-intensity interval training at different times of day on glucose and lipid metabolism, pancreatic β-cell function, sleep quality and exercise self-efficacy in people with Type 2 diabetes

注册题目简写：

English Acronym：

研究课题的正式科学名称：

不同时段节点的高强度间歇运动对2型糖尿病患者糖脂代谢、胰岛β细胞功能、睡眠质量和运动自我效能的影响

Scientific title：

Effects of high-intensity interval training at different times of day on glucose and lipid metabolism, pancreatic β-cell function, sleep quality and exercise self-efficacy in people with Type 2 diabetes

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：

罗秀文 

研究负责人：

罗秀文 

Applicant：

LUO Xiuwen 

Study leader：

LUO Xiuwen 

申请注册联系人电话：

Applicant telephone：

+86 198 2031 8050

研究负责人电话：

Study leader's telephone：

+86 198 2031 8050

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：

sammiluo339@163.com

研究负责人电子邮件：

Study leader's E-mail：

sammiluo339@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

https://www.fsey.com/

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

https://www.fsey.com/

申请注册联系人通讯地址：

广东省佛山市禅城区卫国路78号

研究负责人通讯地址：

广东省佛山市禅城区卫国路78号

Applicant address：

No. 78, Weiguo Road, Chancheng District, Foshan, Guangdong Province, China

Study leader's address：

No.78, Weiguo Road, Chancheng District, Foshan, Guangdong Province, China

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：

广东省佛山市第二人民院

Applicant's institution：

The Second People's Hospital Of Foshan, China

研究负责人所在单位：

广东省佛山市第二人民医院

Affiliation of the Leader：

The Second People's Hospital Of Foshan, China

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

(2023)-0070

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：

佛山市第二人民医院伦理委员会

Name of the ethic committee：

Ethics Committee of The Second People's Hospital Of Foshan

伦理委员会批准日期：

Date of approved by ethic committee：

2023-07-09 00:00:00

伦理委员会联系人：

叶志雄

Contact Name of the ethic committee：

YE Zhixiong

伦理委员会联系地址：

广东省佛山市禅城区卫国路78号

Contact Address of the ethic committee：

No.78, Weiguo Road, Chancheng District, Foshan, Guangdong Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 757 8803 2005

伦理委员会联系人邮箱：

Contact email of the ethic committee：

616780358@qq.com

研究实施负责（组长）单位：

广东省佛山市第二人民医院

Primary sponsor：

The Second People's Hospital Of Foshan, China

研究实施负责（组长）单位地址：

广东省佛山市禅城区卫国路78号

Primary sponsor's address：

No.78, Weiguo Road, Chancheng District, Foshan, Guangdong Province, 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)：

广东

市(区县)：

佛山市

Country：

China

Province：

Guangdong

City：

Foshan

单位(医院)：

佛山市第二人民医院

具体地址：

广东省佛山市禅城区卫国路78号

Institution
hospital：

The Second People's Hospital Of Foshan, China

Address：

No.78, Weiguo Road, Chancheng District, Foshan, Guangdong Province, China

经费或物资来源：

自筹经费

Source(s) of funding：

The funding will be raised by the project team

Target disease：

Diabetes mellitus

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 治疗新技术临床试验 

Study phase：

New Treatment Measure Clinical Study

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

我国2型糖尿病（Type 2 Diabetes Mellitus, T2DM）患病率逐年上升,主要原因是生活方式改变带来的体重超重及肥胖患病率升高。长期代谢紊乱对多脏器造成严重的损伤，并增加医疗费用支出，运动不足成为了T2DM 的独立危险因子。运动疗法是T2DM治疗护理措施中最低成本、经济、简单和效率较高的糖尿病管理措施，也能够给患者带来很多生理和心理上的益处。目前，高强度间歇锻炼（High-intensity interval training，HIIT）能显著提高T2DM患者的健康水平，增强胰岛素敏感性和胰岛β细胞功能，降低了糖化血红蛋白和体重指数，减低心血管并发症，给T2DM 患者带来的更多健康获益。然而，目前高强度间歇运动的开展在国内仍处于探索阶段，HIIT对T2DM患者胰岛β细胞功能的研究较少，且在一天中不同时间段的HIIT可能会影响患者对努力的感知和坚持度，导致对一天中不同时间段的运动锻炼产生不同生理和心理变化而出现血糖波动。因此本研究探讨一天三个不同时间段节点（上午、下午和晚上）的HIIT运动对T2DM患者血糖控制、胰岛β细胞功能、睡眠质量和运动自我效能等方面的影响，研究将得到一天中最适合患者进行HIIT运动的时机，为探索科学有效、更优时间段的结构化运动干预提供临床参考依据。同时将运动锻炼融入日常生活，教会患者健康长寿的科学生活方式，减轻患者心理负担，提升患者生活质量和运动自我效能。远期还可以延缓疾病进展速度，降低终生并发症的发生风险，也使患者及其家庭终身获益，减少糖尿病长期治疗费用支出，使国家受益。  

Objectives of Study：

This study investigated the effects of HIIT exercise at three different time of a day (morning, afternoon and evening) on blood glucose control, pancreatic β-cell function, sleep quality and exercise self-efficacy in people with Type 2 diabetes, and the study also determine the most suitable time of day for people with Type 2 diabetes to perform HIIT training.

药物成份或治疗方案详述：

本研究是一项随机对照研究。以T2DM患者为研究对象进行HIIT干预，探索在一天中三个不同时段节点的高强度间歇运动干预对患者糖代谢、运胰岛素敏感性和患者自我效能的影响。把研究对象随机分为三组，上午时段HIIT干预组（A组）、下午时段HIIT干预组（B组）、晚上时段HIIT干预组（C组）和对照组（D组）进行MICT运动。四组研究对象均接受由糖尿病专科护士为主导的运动干预团队的运动知识传授与指导，同时配合进行糖尿病结构化的护理、健康教育、饮食宣教和预防并发症等的结构化健康教育。另外，A组、B组和C组分别在上午时段（9-10am），下午时段（3-4pm）和晚上时段（7-8pm）进行HIIT干预，D组是对照组，进行MICT运动，干预8周，分别于干预前和干预后测定患者糖代谢各项指标、胰岛β细胞功能、睡眠质量和运动自我效能的指标。 

Description for medicine or protocol of treatment in detail：

This study is a randomized controlled study. People with Type 2 diabetes are the study's participants, HIIT intervention was conducted to explore the effects of high-intensity intermittent exercise intervention at three different time points throughout the day on glucose metabolism, insulin sensitivity, and exercise self-efficacy in people with Type 2 diabetes. We will randomly divide all participants into three groups: Intervention group of morning HIIT training (Group A), intervention group of afternoon HIIT training (Group B), intervention group of evening HIIT training (Group C), and control group (Group D) for MICT training. The four groups participants received the education and guidance of sports knowledge from diabetes specialist nurses. In addition, Group A, Group B, and Group C received HIIT training in the morning (9-10am), afternoon (3-4pm), and evening (7-8pm) respectively. Group D was the control group and underwent MICT training for 8 weeks. Before and after the intervention, various indicators of glucose metabolism and pancreatic β-cell function, sleep quality, and exercise self-efficacy were measured.  

纳入标准：

选取 2024年 1月份到 2024年 5月份在广东省佛山市第二人民医院内分泌科住院部就医的T2DM患者为病例来源。收集内分泌科住院部就医的2型糖尿病患者的临床资料，诊断符合2022年WHO的T2DM 诊断，确诊为2型糖尿病，包括综合既往病史、症状、体征、实验室检测及影像学检查辅助诊断等；年龄18-60岁；T2DM病程≧1年；7.00 %≤HbA1c≤10.00 %；没有进行规律运动锻炼；具有良好的认知和沟通能力，研究期间需严格遵循医嘱服用降血糖血脂药物或注射胰岛素，不可私自更改；受试者尚未接受其他研究干预；所有受试者均知情同意，签署知情同意书，并自愿参与本课题研究。

Inclusion criteria

People with T2DM who were hospitalized in the Endocrinology Department of the Second People's Hospital of Foshan City, Guangdong Province from January 2024 to May 2024 were selected as the case sources. Inclusion criteria: Type 2 diabetes was diagnosed according to the WHO diagnosis of T2DM in 2022, including comprehensive diagnosis of previous history, symptoms, signs, laboratory tests and imaging examinations; Age 18-60 years old; The disease course of T2DM ≧1 year; 7.00 %≤HbA1c≤10.00 %; No regular exercise; Have good cognitive and communication skills, during the study period should strictly follow the doctor's advice to take hypoglycemic and lipid-lowering drugs or insulin injection, do not change; Participants have not received other research interventions; All participants gave informed consent, signed informed consent, and voluntarily participated in the study.

排除标准：

有任何运动禁忌症者，包括下肢或膝关节手术患者等；合并糖尿病急性并发症患者，如糖尿病酮症酸中毒，高渗性高，乳酸性酸中毒等；正处于高血糖状态且患有严重的心、肝、肾功能不全、恶性肿瘤、各种急、慢性感染、有近期有严重外伤、重大手术（6 个月内）患者和使用植入电子装置(如心脏起搏器)的患者；妊娠糖尿病患者；患有糖尿病足溃疡患者；患有原发性或继发性痴呆者。

Exclusion criteria：

Exclusion criteria: Patients with any contraindications to exercise, including patients with lower limb or knee surgery; Patients with acute diabetic complications, such as diabetic ketoacidosis, hyperosmolar acidosis, lactic acidosis, etc. Patients who are currently in a state of hyperglycemia and have severe cardiac, liver, or renal insufficiency, malignant tumors, various acute and chronic infections, recent severe trauma, major surgery (within 6 months), and patients with implanted electronic devices (such as pacemakers); Gestational diabetes mellitus; Patients with diabetic foot ulcers; People with primary or secondary dementia.

研究实施时间：

Study execute time：

从 From 2024-01-01 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-01-01 00:00:00 至 To 2024-05-31 00:00:00  

干预措施：

Interventions：

组别：

上午时段HIIT干预组（A组）

样本量：

23

Group：

Morning HIIT training intervention group (Group A)

Sample size：

干预措施：

患者被纳入研究后接受高强度间歇运动方案。首先在住院期间与患者建立良好的沟通关系，介绍该项运动的目的、意义及相关知识，讲解干预流程，指导患者运动、发放自制运动视频和安排运动时间等。再进行由糖尿病专科护士主导的糖尿病结构化健康教育指导，研究者给患者发放包含饮食、运动、药物、日常护理和健康知识内容的健康指导手册；患者参加由内分泌科医师或糖尿病专科护士在内分泌科举办的糖尿病宣教。再者，依据研究对象个体情况开展HIIT运功干预，干预方式为自行车为运动。运动干预前，研究者为在运动教室运动的患者测试血糖和血压，患者随机血糖＜16.70 mmol/L 或＞5.60 mmol/L，血压＜150/90 mmHg 或＞90/60 mmHg的范围内，且患者无诉不适，可视为运动的安全范围。同时确保患者进食后，并准备好登记表及含糖食品等，预防患者在运动中低血糖。开始时先进行 5 min 蹬车热身运动，负荷档位1-2档。热身运动结束后调整自行车负荷档位，每 10 s 增加 1 档，逐级增加。当患者运动心率达到最大心率的 80 %～90 %且 RPE 指数达到 16～19 级时，停止递增，以高强度蹬车运动状态持续 1 min后，间歇休息 1 min，休息时最大心率30%-40%。以高强度过程 1 min 和休息过程 1 min为 1 组。按照循序渐进的原则，干预第 1 周时，每次运动4 组；第 2 周时，每次运动 6 组；第 3 周时，每次运动 8 组；第 4～8周时，每次运动 10 组。运动结束后依据个体兴趣选择颈部拉伸、三角肌拉伸、腿部拉伸、伸展运动或原地踏步等方式进行 5 min 整理运动。总运动锻炼时长约20-30min，每周一、三、五在康复治疗师与糖尿病专科护士监督下进行运动，其余时间为休息日。护士每周以面谈、电话或微信的方式对患者的饮食、运动、用药和血糖等控制情况进行随访，同时监督患者运动情况，并进行答疑指导。干预时间段节点：上午9-10am；干预运动时长：3 次/周，共 8 周。干预地点：医院心脏康复运动中心。

干预措施代码：

Intervention：

Patients were enrolled in the study and received a high-intensity intermittent exercise regimen. First, establish a good communication relationship with patients during hospitalization, introduce the purpose, significance and related knowledge of the exercise, explain the intervention process, guide patients to exercise, distribute self-made exercise videos and arrange exercise time. Then, the structured diabetes health education guidance led by diabetes nurses was carried out. The researchers distributed health guidance manuals including diet, exercise, medicine, daily care and health knowledge to patients. Patients participate in a diabetes education organized by an endocrinologist or a diabetes nurse in the endocrinology department. Furthermore, HIIT exercise intervention was carried out according to the individual conditions of the subjects, and the intervention method was cycling for exercise. Before exercise intervention, the researchers tested blood glucose and blood pressure for the patients who exercised in the exercise classroom. The patients' random blood glucose < 16.70mmol /L or > 5.60mmol /L, blood pressure < 150/90 mmHg or > 90/60 mmHg, and the patients did not complain of discomfort, could be regarded as the safe range of exercise. At the same time, ensure that patients eat, and prepare the registration form and sugary food, etc., to prevent patients from hypoglycemia during exercise. At the beginning, the warm-up exercise for 5 minutes is performed, and the load gear is 1-2. After the warm-up exercise, adjust the bicycle load gear, increase 1 gear every 10 s, and increase step by step. When the patient's exercise heart rate reaches 80%-90% of the maximum heart rate and the RPE index reaches grade 16-19, the increase is stopped, and after 1 min of high-intensity pedaling, the intermittent rest is 1 min, and the maximum heart rate is 30%-40% at rest. Group 1 was divided into high intensity process 1 min and rest process 1 min. According to the principle of step by step, at the first week of intervention, 4 groups of exercise were performed each time. At week 2, 6 groups were exercised each time. At week 3, 8 groups were exercised each time. From 4 to 8 weeks, exercise 10 groups at a time. After the exercise, choose neck stretching, deltoid stretching, leg stretching, stretching or walking in place and other methods for 5 min finishing exercise according to individual interests. The total exercise duration is about 20-30min. The exercise is conducted on Mondays, Wednesdays and Fridays under the supervision of rehabilitation therapists and diabetes nurses. The rest of the time is rest days. The nurse followed up the patients' diet, exercise, medication and blood sugar control by interview, telephone or wechat every week, supervised the patients' exercise and gave guidance on answering questions. Intervention period node: 9-10am; Duration of intervention exercise: 3 times/week for 8 weeks. Intervention site: Hospital cardiac rehabilitation sports center.

Intervention code：

组别：

下午时段HIIT干预组（B组）

样本量：

23

Group：

Afternoon HIIT training intervention group (Group B)

Sample size：

干预措施：

B组参与对象被纳入研究后，接受HIIT运动方案。HIIT运动方案与A组相同，干预时间段节点分别为：下午3-4pm，干预运动时长：3 次/周，共 8周。干预地点：医院心脏康复运动中心。

干预措施代码：

Intervention：

Participants in group B received HIIT exercise program after being included in the study. The HIIT exercise program was the same as that of group A, and the intervention period nodes were respectively: 3-4pm, and the intervention exercise duration was 3 times/week, for a total of 8 weeks. Intervention site: Hospital cardiac rehabilitation sports center.

Intervention code：

组别：

晚上时段HIIT干预组（C组）

样本量：

23

Group：

Evening HIIT training intervention group (Group C)

Sample size：

干预措施：

C组参与对象被纳入研究后，接受HIIT运动方案。HIIT运动方案与A组和B组相同，干预时间段节点分别为：晚上7-8pm，干预运动时长：3 次/周，共 8周。干预地点：医院心脏康复运动中心。

干预措施代码：

Intervention：

Participants in group C received HIIT exercise program after being included in the study. The HIIT exercise program was the same as that of group A and group B. The intervention time nodes were 7-8pm, and the intervention exercise duration was 3 times/week, for a total of 8 weeks. Intervention site: Hospital cardiac rehabilitation sports center.

Intervention code：

组别：

对照组（D组）

样本量：

23

Group：

Control group (Group D)

Sample size：

干预措施：

对照组患者进行T2DM常规的运动锻炼，中强度连续有氧运动（MICT运动），每周进行 3次，运动方式为自行车，在内分泌科病房进行。其中单次运动有效强度的保持时间至少达到 20 min～30 min，并根据自身情况逐渐延长运动时间，每周一、三、五进行运动，总时长达到 90-150 min，运动心率或摄氧量需达到 50 %～70 %的最大心率。同时接受由糖尿病专科护士主导的糖尿病结构化健康教育指导，包含饮食、运动、药物、日常护理和健康知识等内容。每次时间约为 60 min，每月2次。在8周的干预过程中，共进行4次宣教教育，护士每周同样以面谈或电话或微信的方式对患者的饮食、运动、用药和血糖等控制情况进行随访，并进行答疑指导。

干预措施代码：

Intervention：

The control group underwent T2DM routine exercise, medium intensity continuous aerobic exercise (MICT training) for 3 times a week by bicycle in the endocrinology ward. Among them, the maintenance time of the effective intensity of a single exercise is at least 20 min to 30 min, and gradually extend the exercise time according to their own conditions, every Monday, Wednesday and Friday, the total duration of exercise is 90-150 min, and the exercise heart rate or oxygen uptake needs to reach 50% to 70% of the maximum heart rate. At the same time, we receive structured diabetes health education guidance led by diabetes nurses, including diet, exercise, medicine, daily care and health knowledge. Each time is about 60 minutes, twice a month. In the 8-week intervention process, a total of 4 missions and education were conducted. The nurses also followed up the patients' diet, exercise, medication and blood sugar control by interview or phone or wechat every week, and provided guidance for answering questions.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

 佛山市 

Country：

China 

Province：

Guangdong 

City：

Foshan 

单位(医院)：

佛山市第二人民医院 

单位级别：

三甲 

Institution
hospital：

The Second People's Hospital Of Foshan, China

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

空腹血糖

指标类型：

主要指标

Outcome：

Fasting blood glucose

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

餐后2h血糖

指标类型：

主要指标

Outcome：

2h postprandial blood glucose

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

糖化血红蛋白

指标类型：

主要指标

Outcome：

Glycosylated hemoglobin (Hb1Ac)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

甘油三酯

指标类型：

次要指标

Outcome：

Triglyceride

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

总胆固醇

指标类型：

次要指标

Outcome：

Total cholesterol

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

低密度脂蛋白

指标类型：

次要指标

Outcome：

Low-density lipoprotein

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

高密度脂蛋白

指标类型：

次要指标

Outcome：

High-density lipoprotein

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

OGTT试验（C肽）

指标类型：

主要指标

Outcome：

OGTT test (C-peptide)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

运动期间低血糖事件发生次数

指标类型：

附加指标

Outcome：

The number of hypoglycemic events during exercise

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

运动自我效能

指标类型：

主要指标

Outcome：

Exercise self-efficacy

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

睡眠质量

指标类型：

主要指标

Outcome：

Sleep quality

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

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：

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 60 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）：

本研究拟纳入92名研究对象，按照研究对象入组顺序进行编号，研究对象入组后被随机分配到A、B、C和D四组给予不同的运动干预措施，其中A为上午HIIT锻炼组，B为下午HIIT锻炼组，C为晚上HIIT锻炼组，D为对照组，进行MICT锻炼。每组各23人。使用SPSS电脑统计软件，设定随机数字种子，最后生成了一列新变量Group，即随机分组的结果，以此来确定研究对象的随机分组情况。随机分组的操作由1名计算机中心人员进行。

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

This study intends to include 92 subjects, who will be numbered according to the order of inclusion. After inclusion, the subjects will be randomly assigned to groups A, B, C and D to receive different exercise interventions, among which A is the morning HIIT exercise group, B is the afternoon HIIT exercise group, C is the evening HIIT exercise group, and D is the control group to undergo MICT exercise. Each group consisted of 23 people. SPSS computer statistical software was used to set random number seeds, and finally a new Group of variables was generated, that is, the result of random grouping, so as to determine the random grouping of research objects. The randomization was performed by one researcher who is working in computer center.

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：

本研究的随机对照分组是计算机中心人员进行，利用SPSS随机分组，因此本研究的受试者、研究者（通常是医务工作者）、评估者（疗效考核者）不清楚哪位受试者接受了何种干预运动，这样他们不会受影响。

Blinding：

The randomized control grouping in this study was conducted by computer center personnel, using SPSS randomization, so the subjects, researchers (usually medical workers), and evaluators (efficacy evaluators) in this study did not know which subjects received which intervention exercise, so that they would not be affected.

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

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）：

不打算提供共享原始数据

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

Original data is not intended to be shared

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：

使用电子采集和管理系统

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

Use electronic acquisition and management systems

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2023-12-06 17:00:36