Study on the mechanism of acupuncture for polycystic ovary syndrome with insulin resistance based on multimodal brain imaging and machine learning analysis

注册号:

Registration number:

ITMCTR2024000292

最近更新日期:

Date of Last Refreshed on:

2024-08-24

注册时间:

Date of Registration:

2024-08-24

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

基于机器学习多模态脑影像探讨针刺治疗伴胰岛素抵抗的多囊卵巢综合征的机制研究

Public title:

Study on the mechanism of acupuncture for polycystic ovary syndrome with insulin resistance based on multimodal brain imaging and machine learning analysis

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于机器学习多模态脑影像探讨针刺治疗伴胰岛素抵抗的多囊卵巢综合征的机制研究

Scientific title:

Study on the mechanism of acupuncture for polycystic ovary syndrome with insulin resistance based on multimodal brain imaging and machine learning analysis

研究课题的正式科学名称简写:

Scientific title acronym:

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:

杨晗

研究负责人:

杨晗

Applicant:

Yang Han

Study leader:

Yang Han

申请注册联系人电话:

Applicant telephone:

+86 13880006127

研究负责人电话:

Study leader's telephone:

+86 13880006127

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:

309110036@qq.com

研究负责人电子邮件:

Study leader's E-mail:

309110036@qq.com

申请单位网址(自愿提供):

Study leader's 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:

四川省成都市武侯区国学巷37号

研究负责人通讯地址:

四川省成都市武侯区国学巷37号

Applicant address:

No. 37 Guoxue Alley Wuhou District Chengdu Sichuan Province China

Study leader's address:

No. 37 Guoxue Alley Wuhou District Chengdu Sichuan 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:

四川大学华西医院

Applicant's institution:

West China Hospital of Sichuan University

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

2024年审(1099)号

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

四川大学华西医院生物医学伦理审查委员会

Name of the ethic committee:

Biomedical Ethics Review Committee West China Hospital Sichuan University

伦理委员会批准日期:

Date of approved by ethic committee:

2024/8/13 0:00:00

伦理委员会联系人:

邓绍林

Contact Name of the ethic committee:

Shao-lin Deng

伦理委员会联系地址:

四川省成都市武侯区国学巷37号八角亭2105

Contact Address of the ethic committee:

2105 Bajiao Pavilion 37 Guoxue Lane Wuhou District Chengdu City Sichuan Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

028-85422851

伦理委员会联系人邮箱:

Contact email of the ethic committee:

hxlcyjglb@163.com

研究实施负责(组长)单位:

四川大学华西医院

Primary sponsor:

West China Hospital of Sichuan University

研究实施负责(组长)单位地址:

四川省成都市武侯区国学巷37号

Primary sponsor's address:

No.37 Guoxue Lane Wuhou District Chengdu City Sichuan Province

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川大学华西医院

具体地址:

四川省成都市武侯区国学巷37号

Institution
hospital:

West China Hospital of Sichuan University

Address:

No.37 Guoxue Lane Wuhou District Chengdu City Sichuan Province

经费或物资来源:

四川省自然科学基金

Source(s) of funding:

Natural Science Foundation of Sichuan Province (24NSFSC8170)

研究疾病:

多囊卵巢综合征

研究疾病代码:

Target disease:

polycystic ovarian syndrome

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

其它

Others

研究目的:

基于多模态脑影像信息,挖掘伴胰岛素抵抗的多囊卵巢综合征患者的中枢病理特征和针刺治疗的潜在调控机制;并基于机器学习,构建临床疗效预测模型,优化治疗方案,为针刺的推广应用提供科学证据。

Objectives of Study:

Based on multimodal brain imaging data this study aims to explore the central pathological features of patients with PCOS-IR and the potential regulatory mechanisms of acupuncture treatment. Furthermore by utilizing machine learning we will develop a clinical efficacy prediction model optimize treatment plans and provide scientific evidence for the broader application of acupuncture.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

PCOS-IR受试者: (1)符合PCOS的诊断标准; (2)HOMA-IR ≥ 2.14; (3)18岁≤年龄≤35岁; (4)未处于妊娠期或哺乳期,且近期没有怀孕计划并愿意使用屏障避孕6个月的女性; (5)体内无金属植入物,无MRI扫描禁忌; (6)右利手; (7)进入研究前3个月内未接受针灸或药物治疗; (8)未参加其他正在进行的临床研究; (9)患者签署知情同意书自愿参加本研究者。 注:同时符合以上9项的患者,方可纳入本项研究。 健康受试者: (1)健康情况良好,各项指标及量表评估均正常的女性; (2)无影响认知功能的全身疾病,包括脑中风史、严重的内科疾病、抑郁症、头部外伤史等;最近未服用影响认知功能的药物(抗精神病、抗抑郁和镇静药等);无影响神经心理检查的疾病,包括严重的听力、视力障碍等; (3)18.5 kg/m2 ≤身体质量指数(Body Mass Index, BMI)<24 kg/m2; (4)18岁≤年龄≤35岁; (5)未处于妊娠期或哺乳期; (6)体内无金属植入物,无MRI扫描禁忌; (7)右利手; (8)进入研究前3个月内未接受针灸或药物治疗; (9)未参加其他正在进行的临床研究; (10)患者签署知情同意书自愿参加本研究者。 注:同时符合上述10项的受试者,方可纳入本项研究。

Inclusion criteria

PCOS-IR Participants: 1. Meet the diagnostic criteria for PCOS. 2. HOMA-IR ≥ 2.14. 3. Age between 18 and 35 years. 4. Not currently pregnant or breastfeeding with no plans for pregnancy in the near future and willing to use barrier contraception for six months. 5. No metal implants in the body and no other contraindications for MRI scanning. 6. Right-handed. 7. Have not received acupuncture or medication treatment within the three months prior to entering the study. 8. Not participating in any other ongoing clinical studies. 9. Have signed the informed consent form and voluntarily agreed to participate in this study. Note: Only participants who meet all nine criteria will be included in this study. Healthy Participants: 1. In good health with all indicators and scale assessments normal. 2. No systemic diseases affecting cognitive function; have not recently taken medications that affect cognitive function; and no diseases that affect neuropsychological testing including severe hearing or vision impairments. 3. Body Mass Index (BMI) between 18.5 kg/m² and 24 kg/m². 4. Age between 18 and 35 years. 5. Not currently pregnant or breastfeeding. 6. No metal implants in the body and no other contraindications for MRI scanning. 7. Right-handed. 8. Have not received acupuncture or medication treatment within the three months prior to entering the study. 9. Not participating in any other ongoing clinical studies. 10. Have signed the informed consent form and voluntarily agreed to participate in this study. Note: Only participants who meet all ten criteria will be included in this study.

排除标准:

PCOS-IR受试者: (1)合并其它内分泌或妇科疾病,如糖尿病、促卵泡激素(Follicle-Stimulating Hormone, FSH)>15 mIU/ml、子宫内膜病变、及附件病变者; (2)合并心血管、肝、肾、消化、造血系统等严重原发性疾病者; (3)进展性恶性肿瘤或其它严重消耗性疾病,易合并感染及出血者; (4)意识不清、不能表达主观不适症状者; (5)有出血倾向以及容易发生感染者,或有心律失常、装有心脏起搏器,或患有严重过敏性疾病,或皮肤有溃疡、瘢痕等禁止针刺的患者。 注:凡符合上述任何一条的患者,即应予以排除。 健康受试者: (1)曾有过PCOS病史者; (2)扫描中发现头颅解剖结构严重不对称或有明确病变者; (3)有神经、精神系统家族遗传病史者; (4)不能自主配合完成本次研究者。 注:凡符合上述任何一条的受试者,即应予以排除。

Exclusion criteria:

PCOS-IR Participants: 1. Those with other endocrine or gynecological disorders such as diabetes Follicle-Stimulating Hormone (FSH) > 15 mIU/ml endometrial abnormalities or adnexal abnormalities. 2. Those with severe primary diseases affecting the cardiovascular liver kidney digestive or hematopoietic systems. 3. Those with progressive malignant tumors or other serious diseases prone to infection and bleeding. 4. Those with impaired consciousness who cannot express subjective discomfort. 5. Those with a tendency to bleed easily a high risk of infection arrhythmias implanted pacemakers severe allergic conditions or skin conditions such as ulcers or scars that prohibit acupuncture. Note: Patients who meet any of the above criteria should be excluded. Healthy Participants: 1. Those with a history of PCOS. 2. Those with significant asymmetry in cranial anatomy or clear lesions found during scanning. 3. Those with a family history of neurological or psychiatric disorders. 4. Those unable to independently cooperate in completing this study. Note: Participants who meet any of the above criteria should be excluded.

研究实施时间:

Study execute time:

From 2024-09-01

To      2026-07-31

征募观察对象时间:

Recruiting time:

From 2024-09-10

To      2025-12-31

干预措施:

Interventions:

组别:

针刺经穴组

样本量:

30

Group:

Acupuncture group

Sample size:

干预措施:

真针刺

干预措施代码:

Intervention:

Active Acupuncture

Intervention code:

组别:

针刺非经非穴组

样本量:

30

Group:

Sham acupuncture group

Sample size:

干预措施:

假针刺

干预措施代码:

Intervention:

Sham Acupuncture

Intervention code:

组别:

健康对照组

样本量:

30

Group:

Healthy control group

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

样本总量 Total sample size : 90

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川大学华西医院

单位级别:

三甲

Institution/hospital:

West China Hospital Sichuan University

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

脑核磁共振

指标类型:

次要指标

Outcome:

Brain MRI

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心理健康与生活质量评估相关指标(焦虑自评量表得分、抑郁自评量表得分、多囊卵巢综合征患者生存质量问卷修订版得分、匹兹堡睡眠质量指数得分、爱泼沃斯嗜睡量表得分、疲劳严重程度量表得分、进食态度量表问卷得分)

指标类型:

次要指标

Outcome:

Psychological health and quality of life assessment indicators (Self-Rating Anxiety Scale score Self-Rating Depression Scale score Revised Polycystic Ovary Syndrome Quality of Life Questionnaire score Pittsburgh Sleep Quality Index score Epworth Sleepiness Scale score Fatigue Severity Scale score Eating Attitudes Test score)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肠道菌群

指标类型:

次要指标

Outcome:

Intestinal flora

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

干预措施评价指标(针灸期待值评价、临床总体印象量表)

指标类型:

次要指标

Outcome:

Intervention assessment indicators (Acupuncture Expectancy Evaluation Clinical Global Impression Scale)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胰岛素抵抗指数

指标类型:

主要指标

Outcome:

HOMA-IR

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

高雄相关症状测量(FG评分、Rosenfield评分)

指标类型:

次要指标

Outcome:

Measurements of hyperandrogenism-related symptoms (FG score Rosenfield score)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

糖脂代谢相关指标(空腹葡萄糖、空腹胰岛素、葡萄糖曲线下面积、胰岛素曲线下面积、胰岛β细胞功能指数、总胆固醇、甘油三酯、高密度脂蛋白胆固醇、低密度脂蛋白胆固醇、非高密度脂蛋白胆固醇)

指标类型:

次要指标

Outcome:

Indicators related to glucose and lipid metabolism (fasting glucose fasting insulin area under glucose curve area under insulin curve HOMA-β total cholesterol triglycerides HDL cholesterol LDL cholesterol non-HDL 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:

激素情况(黄体生成素/促卵泡刺激素、总睾酮、游离雄激素指数、硫酸脱氢表雄酮)

指标类型:

次要指标

Outcome:

Hormonal profile (Luteinizing Hormone/Follicle-Stimulating Hormone ratio total testosterone Free Androgen Index Dehydroepiandrosterone Sulfate)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

认知行为学相关指标(动物词语流畅性测试得分、数字匹配测试得分、计划编码测试得分、计划连接测试得分、非语言矩阵测试得分、言语-空间关系测试得分、图形记忆测试得分、表达性注意测试得分、数字检测测试得分、接受性注意测试得分、单词系列测试得分、句子重复测试得分、句子问题测试得分)

指标类型:

次要指标

Outcome:

Cognitive-behavioral assessment indicators (Animal Verbal Fluency Test Matching Numbers Planned Coding Planned Connection Non-verbal Matrix Verbal Spatial Relationship Figure Memory Expressive attention Number Detection Receptive Attention Word Series Sentence Repetition Sentence Question)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗和随访期间的不良事件

指标类型:

副作用指标

Outcome:

Adverse events during treatment and follow-up

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

人体测量相关指标(身体质量指数、体重、腰围、臀围、腰臀比)

指标类型:

次要指标

Outcome:

Anthropometric indicators (Body Mass Index weight waist circumference hip circumference waist-to-hip ratio)

Type:

Secondary 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:

标本中文名:

粪便

组织:

Sample Name:

Faeces

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:

尚未开始

Not yet recruiting

年龄范围:

最小 18
Min age years
最大 35
Max age years

Recruiting status:

Participant age:

性别:

Gender:

女性

Female

随机方法(请说明由何人用什么方法产生随机序列):

本部分研究使用SPSS 22.0制作随机数字表。

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

This part of the research uses SPSS 22.0 to make a random number table.

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

Yes

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):

暂未确定

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

Not yet determined.

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:

病例记录表由专人记录,电子采集和管理系统由Excel完成。

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

The Case Record Form was recorded by a special person and the electronic collection and management system was completed by Excel.

数据管理委员会:

Data Managemen Committee:

暂未确定

Not yet

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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