ChiCTR2300076319 版本V1.1 版本创建时间2024/03/09 10:00:55 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：

 ChiCTR2300076319 

最近更新日期：

Date of Last Refreshed on：

 2023-10-01 19:23:12 

注册时间：

Date of Registration：

 2023-10-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于数据驱动建模的针灸减肥深层机理研究

Public title：

Study on the deep mechanism of acupuncture weight loss based on data-driven modeling

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于数据驱动建模的针灸减肥深层机理研究

Scientific title：

Study on the deep mechanism of acupuncture weight loss based on data-driven modeling

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：

李晓民 

研究负责人：

李晓民 

Applicant：

Xiaomin LI 

Study leader：

Xiaomin LI 

申请注册联系人电话：

Applicant telephone：

 +86 561 304 2095

研究负责人电话：

Study leader's
telephone：

+86 133 0561 5138

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：

 lxmyu1226@126.com

研究负责人电子邮件：

Study leader's E-mail：

 lxmyu1226@126.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 淮北市人民医院

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：

安徽省淮北市人民医院中医科

研究负责人通讯地址：

安徽省淮北市人民医院中医科

Applicant address：

Department of Traditional Chinese Medicine, Huaibei People's Hospital, Anhui Province

Study leader's address：

Department of Traditional Chinese Medicine, Huaibei People's Hospital, Anhui Province

申请注册联系人邮政编码：

Applicant postcode：

 235200

研究负责人邮政编码：

Study leader's postcode：

 235200

申请人所在单位：

淮北市人民医院

Applicant's institution：

Huaibei People's Hospital

研究负责人所在单位：

淮北市人民医院

Affiliation of the Leader：

Huaibei People's 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：

 伦审第2022-26号

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：

淮北市人民医院伦理委员会

Name of the ethic committee：

Ethics Committee of Huaibei People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-10-08 00:00:00

伦理委员会联系人：

周谦让

Contact Name of the ethic committee：

Qianrang ZHou

伦理委员会联系地址：

安徽省淮北市人民医院伦理委员会

Contact Address of the ethic committee：

Ethics Committee of Huaibei People's Hospital, Anhui Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 561 304 5046

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 lxmyu1226@126.com

研究实施负责（组长）单位：

淮北市人民医院

Primary sponsor：

Huaibei People's Hospital

研究实施负责（组长）单位地址：

安徽省淮北市淮海西路66号

Primary sponsor's address：

66 Huaihai West Road, Huaibei City, Anhui 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)：

安徽省

市(区县)：

淮北市

Country：

china

Province：

Anhui Province

City：

Huaibei

单位(医院)：

淮北市人民医院

具体地址：

安徽省淮北市淮海西路66号

Institution
hospital：

Huaibei People's Hospital

Address：

66 Huaihai West Road, Huaibei City, Anhui Province, China

经费或物资来源：

单位匹配

Source(s) of funding：

Matching of units

研究疾病：

肥胖  

Target disease：

obesity

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：

 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：

本课题旨通过电针和穴位埋线两种针灸干预方法，配合营养和运动，观察干预治疗前后，患者人体成分分析仪参数，BMI、血脂、血糖、血压以及中医证候评分等常规指标变化，通过MRI平扫，以肚脐为解剖平面的脂肪分布和形态学变化，同时观察肝脏等内脏脂肪含量变化、下丘脑的脂肪含量和体积变化等情况，数据驱动建模挖掘其大量临床数据的内在关联性，探讨其深层次机制，为针灸治疗单纯性肥胖建立更多客观证据。  

Objectives of Study：

The purpose of this study is to observe the changes of body composition analyzer parameters, body mass index (BMI), blood lipid, blood glucose, blood pressure, and traditional Chinese medicine (TCM) syndrome scores before and after the intervention of electroacupuncture and acupoint catgut embedding, and to observe the changes of fat distribution and morphology at the anatomical plane of the belly button by MRI plain scan. At the same time, the changes of liver and other visceral fat content and the changes of fat content and volume of hypothalamus were observed, and data-driven modeling was used to mine the internal correlation of a large number of clinical data, explore its deep mechanism, and establish more objective evidence for acupuncture and moxibustion in the treatment of simple obesity.

药物成份或治疗方案详述：

针刺由中医主治及以上执业医师，并在相应医院工作至少5年的经认证针灸医师进行操作，营养管理组由具有国家认证的高级营养师进行全程指导。在试验之前，所有针灸医师都必须接受特殊培训，以便充分了解治疗效果，只有通过考核的人才有资格参加试验。培训内容包括穴位定位、针刺手法操作、穴位埋线等技术规范。 具体操作流程参照《针灸技术操作规范第20部分：毫针基本刺法》国家标准（GB/T 21709.20-2009）进行，流程如下： 消毒：包括操作者手消毒和针刺部位消毒。 操作者手消毒：施针之前，医生先用肥皂水将双手刷洗干净，待干后用75%的酒精棉球擦拭后方可持针操作。 针刺部位消毒：在需要针刺的腧穴皮肤处用75%的酒精棉球擦拭消毒，擦拭时从穴位的中心点向外环绕消毒。体位：根据不同的取穴方案，采取仰卧位。 选穴：中脘、下脘、关元，及双侧天枢、大横、带脉、足三里、丰隆、三阴交、风市、臂臑，阿是穴。腧穴定位参照2006年中华人民共和国国家标准（GB/T 12346-2006）《腧穴名称和定位》。 MRI扫描方法 所有受试者MRI和1H-MRS 检查均采用 Philips Achieva3.0T MRI 扫描仪使用 Sense Torso 线圈。检查前晚禁食10h。针灸治疗前、后分别进行两次同样的 MR 扫描及数据采集。 腹部脂肪MRI：采用 T1W TFE 序列采集轴位 T1WI （TR／TE10ms／2?3ms flip angle15°）。采集范围：以脐为截面进行扫描。 采用呼吸触发模式进行扫描。 采用 segmentation 软件在MRI工作站上测量脂肪相关参数。肝脏1H-MRS 检查：对受试者行轴位、冠状位及矢状位成像再以肝门水平在矢、冠、轴位选取肝右叶为主，尽量多包含肝组织避开肝 内较大血管、胆管及肝边缘。头颅MRI主要薄层扫描下丘脑部位，测量体积和脂肪含量， 每次扫描前进行波谱体模扫描。 数据分析采用 Philips Achieva3.0T 波谱分析软件进行化学位移的定量谱分析。 A组：营养管理组 对入选患者进行常规干预:运动+健康饮食疗法。运动干预:有氧运动+无氧运动(根据自身情况选择有氧运动如快走、游泳、慢跑等；每周4~5次，每次运动30~60 min；无氧运动如深蹲、平板支撑等，每周2~3次，每次运动10~20 min。第1周运动目标心率不超过65%最大心率(HRmax =220一生理年龄)，后期可达75%最大心率。可根据患者自身条件进行调整。饮食干预:每日能量摄入量：基本标准体重*20kcal/kg；蛋白质：体重*2.2g；三餐能量比例分配为蛋白质30% 、碳水化合物40%和脂肪30%。由专门营养师根据患者身体需要，进行个体化调节，保证身体健康的基础上，进行个体化计算，禁碳酸饮料、烟酒、煎炸等高热量、高糖量食物。)疗程:6周为1个疗程，疗程对照观察疗效指标。 B组：电针组； 在营养管理干预的基础上，根据患者的主要兼症表现，参考《针灸治疗学》及储浩然教授临床经验进行针灸主配穴治疗。 取穴：主穴取中脘、下脘、关元，及双侧天枢、大横、带脉、足三里、丰隆、三阴交、风市、臂臑以及脂肪堆积部位阿是穴。 配穴：肠热腑实配上巨虚、内庭；脾胃虚弱配脾俞；肾阳亏虚配肾俞；少气懒言配太白；心悸配神门、内关；便秘配支沟；嗜睡配照海、申脉。 操作：常规消毒后，根据肌肉丰厚程度不同选用一次性无菌针灸针（无锡佳健医疗器械股份有限公司），规格为0.3mm×（25～60）mm，直刺进针10～25mm，得气后接G6805-Ⅲ型电针仪型电子针灸治疗仪（无锡佳健医疗器械股份有限公司）。腰腹部肥胖明显者，电针接于中脘、气海及双侧天枢、带脉；下肢肥胖明显者，电针接于足三里和风市及脂肪堆积部位。采用疏密波，频率30Hz，以局部轻微抖动为度，留针40min。每周电针治疗3次，治疗至少间隔1d，并配合每周1次营养干预，连续6周。疗程对照观察疗效指标。 C组:穴位埋线组。 在医学营养管理和运动的基础上，患者进行穴位治疗，埋线选穴同电针组。 埋线方法：于腧穴部常规消毒后，带无菌手套，手持无菌镊子，右手持一次性埋线针（0.9号 苏州市吴中区东方针灸器械厂），将针芯稍微后抽，将可吸收外科线穿入针管前端。左手拇食指置于腧穴两侧，使局部皮肤绷紧，右手持针快速刺入皮肤并缓慢推至所需深度，当出现针感后，边退针管，边推送针芯，使可吸收外科线埋植在皮下组织或肌层内，针孔处贴医用创可贴。嘱埋线者当天不洗澡，不出汗，穴位部8 h内勿与水接触。疗程:1次/2周,3次为1个疗程。疗程间休息2周后再进行下1个疗程，共3个疗程(月经期暂停治疗)。疗程对照观察疗效指标。 

Description for medicine or protocol of treatment in detail：

Acupuncture was performed by certified acupuncture-moxibustion physicians who were attending TCM or above and had worked in the corresponding hospitals for at least 5 years. The nutrition management group was guided by national certified senior dietitian throughout the process. Prior to the trial, all acupuncturists had to undergo special training in order to fully understand the treatment effects, and only those who passed the examination were eligible to participate in the trial. The training content included acupoint positioning, acupuncture manipulation, acupoint thread-embedding and other technical specifications. The detailed operation process was carried out according to the national standard of "Technical Specifications of Acupuncture and Moxibustion Part 20: Basic Acupuncture Technique of filiform Needle" (GB/T 21709.20-2009), and the process was as follows: Disinfection: including operator's hand disinfection and needle-site disinfection. Operator hand disinfection: before applying needles, the doctor first scrub the hands with soapy water, and wipe them with a 75% alcohol cotton ball before holding the needles. Acupuncture site disinfection: wipe the skin of acupoints to be needled with 75% alcohol cotton ball for disinfection, and wipe from the center of the acupoint to the outside of the disinfection. Position: According to different acupoint selection schemes, the patients were in the supine position. Selected acupoint: Zhongwan (CV 12), Xiawan (CV 12), Guanyuan (CV 4), bilateral Tianshu (ST 25), Daheng (GV 20), bamai (also called by bambi), Zusanli (ST 36), Fenglong (ST 40), Sanyinjiao (SP 6), Fengshi (also called by bambi) and bambi (also called by bambi). The acupoint location was referred to the national standard of the People's Republic of China (GB/T 12346-2006), Name and Location of acupoint. MRI scanning Methods All subjects underwent MRI and 1H-MRS using Philips Achieva3.0T MRI scanner with Sense Torso coil. Fasting was 10h the night before the examination. The same MR Scan and data acquisition were performed twice before and after acupuncture treatment. Abdominal fat MRI: T1W TFE sequence was used to acquire axial T1WI (TR/TE10ms / 2?3ms flip angle15°). Range of acquisition: The umbilicus was scanned as a cross section. Scanning was performed in the respiratory trigger mode. The segmentation software was used to measure fat-related parameters on the MRI workstation. 1H-MRS examination of the liver: the subjects were imaged in axial, coronal and sagittal planes, and the right lobe of the liver was selected at the level of the hepatic hilum in sagittal, coronal and axial planes, and the liver tissue was included as much as possible to avoid the large blood vessels, bile ducts and the edge of the liver. The volume and fat content of hypothalamus were measured by thin-slice MRI. Spectral phantom scanning was performed before each scan. Philips Achieva3.0T spectroscopic analysis software was used for quantitative analysis of chemical shift. Group A: nutrition management group The selected patients were given routine intervention: exercise + healthy diet therapy. Exercise intervention: aerobic exercise + anaerobic exercise (according to their own conditions to choose aerobic exercise such as fast walking, swimming, jogging, etc.; 4 to 5 times a week, 30 to 60 minutes each time; Anaerobic exercises such as squats and plank support were performed 2 to 3 times a week for 10 to 20 minutes each time. In the first week, the target heart rate did not exceed 65% of the maximum heart rate (HRmax =220 - physiological age), and it could reach 75% of the maximum heart rate in the later period. It can be adjusted according to the patient's own conditions. Dietary intervention: daily energy intake: basic standard body weight *20kcal/kg; Protein: body weight *2.2g; The proportion of energy in three meals was allocated to 30% protein, 40% carbohydrate and 30% fat. According to the needs of the patient's body, individualized adjustment by specialized nutritionists, on the basis of ensuring the health of the body, individualized calculation, prohibition of carbonated drinks, tobacco and alcohol, fried and other high calorie, high sugar food. Treatment course :6 weeks as a course of treatment, treatment course was compared to observe the efficacy indicators. Group B: EA group; On the basis of nutritional management intervention, according to the patient's main concurrent symptoms, referring to Acupuncture and Moxibustion Therapy and Professor Chu Hao-ran's clinical experience, the main acupoints of acupuncture and moxibustion were treated. The main acupoint is Zhongwan (CV 12), Xiawan (CV 12), Guanyuan (CV 4), and bilateral Tianshu (ST 25), Daheng (GB 5), bamai (also called by bambi), Zusanli (ST 36), Fenglong (ST 40), Sanyinjiao (SP 6), Fengshi (also called by bambi) and Ashis (also called by bambi). The matching acupoints are as follows: the intestinal heat fu fu is solid matched with Juxu and Neiting. Spleen-stomach weakness combined with Pishu; Kidney Yang deficiency with Shenshu; Less gas lazy words match too white; Palpitation with Shenmen and Neiguan; Constipation with branch gully; Drowsiness with the sea, Shen mai. Operation: After routine disinfection, disposable sterile acupuncture needle (Wuxi Jiajia Medical Instrument Co., LTD.) was selected according to the degree of muscle fat, the size was 0.3mm× (25-60) mm, the straight insertion needle was 10-25 mm, and after qi was obtained, G6805-Ⅲ type electroacupuncture instrument electronic acupuncture therapeutic instrument (Wuxi Jiajia Medical Instrument Co., LTD.) was connected. For the patients with obvious waist and abdomen obesity, EA was applied to Zhongwan (CV 12), Qihai (CV 6), bilateral Tianshu (ST 25) and Daibai (Dai Mai). Ea was applied to Zusanli (ST 36), Fengshi (ST 36) and fat accumulation sites in patients with obvious lower limb obesity. A disperse-dense wave with a frequency of 30Hz and a degree of local slight jitter was used, and the needle was retained for 40min. Ea was given 3 times a week, with an interval of at least 1 day, combined with nutritional intervention once a week for 6 weeks. The treatment course was compared to observe the efficacy indicators. Group C: acupoint thread-embedding group. On the basis of medical nutrition management and exercise, the patients were treated with acupoint therapy, and the acupoint selection was the same as that of the EA group. The thread embedding method: after routine disinfection of the acupoints, the disposable thread-embedding needle (No.0.9 Dongfang Acupuncture Instrument Factory, Wuzhong District, Suzhou City) is held in the right hand with sterile gloves and sterile tweezer. The needle core is slightly pulled back, and the absorbable surgical thread is threaded into the front of the needle tube. The thumb and index finger of the left hand are placed on both sides of the acupoint to tighten the local skin, while the needle is held in the right hand to quickly Pierce the skin and slowly push to the required depth. When the needle feeling occurs, the needle tube is withdrawn while the needle core is pushed, so that the absorbable surgical thread is embedded in the subcutaneous tissue or muscle layer, and a medical band-aid is placed at the needle hole. The catgut embedding patients were instructed not to take a bath or sweat on the same day, and not to contact with water at the acupoint within 8 hours. The course of treatment was once /2 weeks,3 times as a course of treatment. There was a 2-week interval before the next course of treatment, and a total of 3 courses (menstrual period was suspended). The treatment course was compared to observe the efficacy indicators. 

纳入标准：

（1）符合上述诊断标准，确诊为单纯性肥胖患者;（2）年龄18~58岁，性别不限;（3）自愿接受各种针灸治疗并配合进行各项检测，能配合完成整个治疗过程，所有患者均对签署治疗知情同意书。

Inclusion criteria

(1) Patients were diagnosed as simple obesity according to the above diagnostic criteria; (2) Age of 18-58 years old, both sexes; (3) All patients were willing to accept various acupuncture treatments and cooperate with various tests, and could cooperate to complete the whole treatment process. All patients signed the informed consent for treatment.

排除标准：

（1）继发性肥胖患者;（2）有糖尿病、重大心脑肝肾等器质性疾病、感染性疾病、血液系统疾病、精神疾病患者;（3） 一个月内接受过与本病相关的中西医治疗者；（4） 病情危重，难以对本治疗的有效性和安全性作出确切评价者；（5）某种原因未按规定接受或完成治疗无法判断疗效或资料不全者；（6）依从性差，不能坚持治疗者；（7）妊娠及哺乳期妇女。（8）有MRI检查禁忌症者。

Exclusion criteria：

(1) patients with secondary obesity; (2) patients with diabetes, major organic diseases such as heart, brain, liver and kidney, infectious diseases, hematological diseases, and mental diseases; (3) those who had received traditional Chinese and western medicine treatment related to the disease within one month; (4) It is difficult to make a definite assessment of the efficacy and safety of the treatment. (5) Failure to receive or complete the treatment according to the regulations for some reason, inability to judge the efficacy, or incomplete data; (6) poor compliance, unable to adhere to the treatment; (7) pregnant and lactating women. (8) patients with contraindications to MRI examination.

研究实施时间：

Study execute time：

从 From 2022-12-01 00:00:00至 To 2024-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-10-10 00:00:00 至 To 2024-05-10 00:00:00

干预措施：

Interventions：

组别：

营养管理组

样本量：

 35

Group：

Nutrition Management Section

Sample size：

干预措施：

营养管理

干预措施代码：

 C

Intervention：

Nutrition management

Intervention code：

组别：

电针组

样本量：

 35

Group：

Electroacupuncture group

Sample size：

干预措施：

电针

干预措施代码：

 A

Intervention：

Electroacupuncture

Intervention code：

组别：

穴位埋线组

样本量：

 35

Group：

Acupoint thread-embedding group

Sample size：

干预措施：

穴位埋线

干预措施代码：

 B

Intervention：

acupoint catgut embedding

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 安徽省 

市(区县)：

 淮北 

Country：

China

Province：

Anhui Province

City：

Huaibei City

单位(医院)：

 淮北市人民医院 

单位级别：

 三级甲等医院 

Institution
hospital：

Huaibei People's Hospital

Level of the institution：

grade iii-a general hospital

测量指标：

Outcomes：

指标中文名：

身体质量指数

指标类型：

主要指标

Outcome：

body mass index(BMI)

Type：

Primary indicator

测量时间点：

治疗前后

测量方法：

人体成份分析仪

Measure time point of outcome：

pretherapy and post-treatment

Measure method：

Human body composition analyzer

指标中文名：

人体成分分析

指标类型：

主要指标

Outcome：

Body Composition Analysis

Type：

Primary indicator

测量时间点：

治疗前后

测量方法：

人体成份分析仪

Measure time point of outcome：

pretherapy and post-treatment

Measure method：

Human body composition analyzer

指标中文名：

腰臀比

指标类型：

次要指标

Outcome：

waist hip rate

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

人工计算

Measure time point of outcome：

pretherapy and post-treatment

Measure method：

manual computation

指标中文名：

血脂

指标类型：

次要指标

Outcome：

blood fat

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

机器

Measure time point of outcome：

pretherapy and post-treatment

Measure method：

machine

指标中文名：

血糖

指标类型：

次要指标

Outcome：

blood glucose

Type：

Secondary indicator

测量时间点：

治疗前后

测量方法：

机器

Measure time point of outcome：

pretherapy and post-treatment

Measure method：

指标中文名：

肝脏精准定量分析

指标类型：

主要指标

Outcome：

Precise quantitative analysis of the liver

Type：

Primary indicator

测量时间点：

治疗前后

测量方法：

3.0T MRI

Measure time point of outcome：

pretherapy and post-treatment

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 58 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）：

随机数字表法

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

Random number table method

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：

本试验采用单盲法及第三者评价法，即受试者不了解在试验中的分组处理情况

Blinding：

this trial uses the single-blind method and the third party evaluation method, that is, the subjects do not know the grouping and treatment in the trial

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）：

无

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

None.

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：

CRF,SPSS20

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

CRF,SPSS20

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：

  2023-10-01 19:22:46