Cross-sectional Study on the TCM Syndrome of Damp-Heat in Glycolipid Metabolic Diseases Based on Multi-omics Technology

注册号:

Registration number:

ITMCTR2024000300

最近更新日期:

Date of Last Refreshed on:

2024-08-26

注册时间:

Date of Registration:

2024-08-26

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

基于多组学技术探讨糖脂代谢性疾病中医湿热证的横断面研究

Public title:

Cross-sectional Study on the TCM Syndrome of Damp-Heat in Glycolipid Metabolic Diseases Based on Multi-omics Technology

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于多组学技术探讨糖脂代谢性疾病中医湿热证的横断面研究

Scientific title:

Cross-sectional Study on the TCM Syndrome of Damp-Heat in Glycolipid Metabolic Diseases Based on Multi-omics Technology

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:

董昭熙

研究负责人:

柳红芳

Applicant:

Dong Zhaoxi

Study leader:

Liu hongfang

申请注册联系人电话:

Applicant telephone:

+86 18810058657

研究负责人电话:

Study leader's telephone:

+86 188 0117 5242

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:

380421851@qq.com

研究负责人电子邮件:

Study leader's E-mail:

lhfdoctor@126.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:

北京市朝阳区北三环东路11号北京中医药大学

研究负责人通讯地址:

北京市东城区海运仓5号北京中医药大学东直门医院

Applicant address:

Beijing University of Chinese Medicine, No.11, East Beisanhuan Road, Chaoyang District, Beijing

Study leader's address:

Dongzhimen Hospital, Beijing University of Chinese Medicine, No. 5 Haiyuncang, Dongcheng District, Beijing

申请注册联系人邮政编码:

Applicant postcode:

100029

研究负责人邮政编码:

Study leader's postcode:

100700

申请人所在单位:

北京中医药大学

Applicant's institution:

Beijing University of Traditional Chinese Medicine

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:

2022DZMEC-159-05

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:

北京中医药大学东直门医院医学伦理委员会

Name of the ethic committee:

The Medical Ethics Committee of Dongzhimen Hospital, Beijing University of Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2022/7/27 0:00:00

伦理委员会联系人:

韩雪婷

Contact Name of the ethic committee:

Han Xueting

伦理委员会联系地址:

北京市东城区海运仓5号北京中医药大学东直门医院

Contact Address of the ethic committee:

Dongzhimen Hospital, Beijing University of Chinese Medicine, No. 5 Haiyuncang, Dongcheng District, Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 10 8401 2709

伦理委员会联系人邮箱:

Contact email of the ethic committee:

dzmyyec@126.com

研究实施负责(组长)单位:

北京中医药大学东直门医院

Primary sponsor:

Dongzhimen Hospital, Beijing University of Chinese Medicine

研究实施负责(组长)单位地址:

北京市东城区海运仓胡同5号

Primary sponsor's address:

5 Haiyuncang Hutong, Dongcheng District, Beijing

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京市

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京中医药大学东直门医院

具体地址:

东城区海运仓胡同5号

Institution
hospital:

Dongzhimen Hospital, Beijing University of Chinese Medicine

Address:

5 Haiyuncang Hutong, Dongcheng District

经费或物资来源:

广东省科技创新战略专项资金;广东省基础与应用基础研究基金;基础与应用基础重大项目

Source(s) of funding:

Special fund for scientific and technological innovation strategy of Guangdong Province; Foundation of basic and applied research of Guangdong Province; Major basic and application projects

研究疾病:

糖脂代谢性疾病

研究疾病代码:

Target disease:

Glycolipid Metabolic Diseases

Target disease code:

研究类型:

Study type:

观察性研究

Observational study

研究设计:

Study design:

析因分组(即根据危险因素或暴露因素分组)

Factorial

研究所处阶段:

Study phase:

探索性研究/预试验

Pilot clinical trial

研究目的:

探索糖脂代谢性疾病湿热证的生物学基础研究,通过对正常对照组、糖尿病湿热证组、糖尿病非湿热证组、湿热证非糖尿病组(肥胖、高脂血症)患者一般信息及临床指标的观察、对比分析,以期对糖脂代谢性疾病湿热证的生物学基础进行相关探索及研究。

Objectives of Study:

To explore the biological basis of damp-heat syndrome in glucose and lipid metabolic diseases. Through the observation and comparative analysis of the general information and clinical indicators of the normal control group, the diabetic damp-heat syndrome group, the diabetes non-damp-heat syndrome group, and the damp-heat syndrome non-diabetic group (obesity, hyperlipidemia), to explore and study the biological basis of the glucolipid metabolic disease damp-heat syndrome.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

(1)糖尿病湿热证组纳入标准 ①18≤年龄≤75,性别不限;②符合T2DM诊断标准与中医湿热证诊断标准;③签署知情同意。 (2)糖尿病非湿热证组纳入标准 ①18≤年龄≤75,性别不限;②符合T2DM诊断标准与中医非湿热证诊断标准;③签署知情同意。 (3)湿热证非糖尿病组纳入标准 ①18≤年龄≤75,性别不限;②符合中医湿热证诊断标准;③符合肥胖症或高脂血症诊断标准之一;④受试者无 2 型糖尿病的危险因素,空腹血糖水平<6.1mmol/L,糖化血红蛋白 (HbA1c)<5.7%(葡萄糖代谢正常);⑤签署知情同意。 (4)正常对照组纳入标准 ①18≤年龄≤75,性别不限;②符合正常对照组诊断标准;③签署知情同意。

Inclusion criteria

(1) Inclusion Criteria for Diabetic Patients with Damp-Heat Syndrome ① Age range from 18 to 75 years old, regardless of gender; ② Meet the diagnostic criteria for Type 2 Diabetes Mellitus (T2DM) and the diagnostic criteria for Damp-Heat Syndrome in Traditional Chinese Medicine (TCM); ③ Provide signed informed consent. (2) Inclusion Criteria for Diabetic Patients without Damp-Heat Syndrome ① Age range from 18 to 75 years old, regardless of gender; ② Meet the diagnostic criteria for T2DM and the diagnostic criteria for non-Damp-Heat Syndrome in TCM; ③ Provide signed informed consent. (3) Inclusion Criteria for Non-Diabetic Individuals with Damp-Heat Syndrome ① Age range from 18 to 75 years old, regardless of gender; ② Meet the diagnostic criteria for Damp-Heat Syndrome in TCM; ③ Meet at least one of the diagnostic criteria for obesity or hyperlipidemia; ④ Subjects without risk factors for Type 2 Diabetes Mellitus, with fasting blood glucose levels < 6.1 mmol/L and glycated hemoglobin (HbA1c) < 5.7% (indicating normal glucose metabolism); ⑤ Provide signed informed consent. (4) Inclusion Criteria for Normal Control Group ① Age range from 18 to 75 years old, regardless of gender; ② Meet the diagnostic criteria for the normal control group; ③ Provide signed informed consent.

排除标准:

1. 合并心、肝、肾、内分泌等系统原发疾病或急慢性胃肠疾病的患者; 2. 有精神疾病的患者; 3. 妊娠或哺乳期患者; 4. 近2个月服用可能影响肠道菌群药物者,如抗生素、黄连素、通便药物、双歧杆菌等; 5. 采样1月内接受过外用灌肠疗法者。

Exclusion criteria:

1. Patients with primary diseases of heart, liver, kidney, endocrine system or acute and chronic gastrointestinal diseases; 2. Patients with mental illness; 3. Pregnant or lactating patients; 4. Taking drugs that may affect intestinal flora in recent 2 months, such as antibiotics, berberine, defecation drugs, bifidobacteria, etc; 5. Those who had received external enema therapy within 1 month before sampling.

研究实施时间:

Study execute time:

From 2022-08-23

To      2024-12-31

征募观察对象时间:

Recruiting time:

From 2022-08-23

To      2024-07-19

干预措施:

Interventions:

组别:

湿热证非糖尿病组

样本量:

24

Group:

Non diabetic group with damp heat syndrome

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

Intervention code:

组别:

糖尿病湿热证组

样本量:

24

Group:

Diabetes mellitus patients with syndrome of damp-heat

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

Intervention code:

组别:

正常对照组

样本量:

24

Group:

Normal control group

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

Intervention code:

组别:

糖尿病非湿热证组

样本量:

24

Group:

Diabetes non damp heat syndrome group

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

Intervention code:

样本总量 Total sample size : 96

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

北京市

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京中医药大学东直门医院

单位级别:

三级甲等医院

Institution/hospital:

Dongzhimen Hospital, Beijing University of Chinese Medicine

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

舌微循环图像

指标类型:

主要指标

Outcome:

Tongue microcirculation image

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

便标本扩增子

指标类型:

主要指标

Outcome:

fecal sample amplicon

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

口腔标本宏基因

指标类型:

主要指标

Outcome:

oral metagenome

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规

指标类型:

次要指标

Outcome:

routine blood test

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

便样本菌群检测

指标类型:

主要指标

Outcome:

Stool sample flora detection

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

口腔标本扩增子

指标类型:

主要指标

Outcome:

oral sample amplicon

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

腰臀比(WHR)

指标类型:

次要指标

Outcome:

Waist-to-Hip Ratio (WHR)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿肌酐

指标类型:

次要指标

Outcome:

Urinary creatinine

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医信息

指标类型:

主要指标

Outcome:

Traditional Chinese Medicine information

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

既往史

指标类型:

次要指标

Outcome:

Past medical history

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

便标本代谢组学

指标类型:

主要指标

Outcome:

metabolomics of fecal samples

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血样本代谢组学

指标类型:

主要指标

Outcome:

Metabolomics of blood samples

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿样本水分子检测

指标类型:

主要指标

Outcome:

Detection of water molecules in urine samples

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

口腔标本代谢组学

指标类型:

主要指标

Outcome:

metabolomics of oral samples

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿样本代谢组学

指标类型:

主要指标

Outcome:

Metabolomics of urine samples

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

便常规

指标类型:

次要指标

Outcome:

Stool routine

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

糖化血红蛋白

指标类型:

主要指标

Outcome:

glycosylated hemoglobin

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血样本单细胞测序

指标类型:

主要指标

Outcome:

Single cell sequencing of blood samples

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

年龄

指标类型:

次要指标

Outcome:

Age

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血糖

指标类型:

主要指标

Outcome:

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:

舌象彩色照片检查

指标类型:

主要指标

Outcome:

Tongue color photo examination

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿样本蛋白质组学

指标类型:

主要指标

Outcome:

Urine sample proteomics

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

口腔标本蛋白组学

指标类型:

主要指标

Outcome:

proteomics of oral samples

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血样本western blot验证

指标类型:

主要指标

Outcome:

Western blot verification of blood samples

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

眼底彩色照片检查

指标类型:

主要指标

Outcome:

Fundus color photograph examination

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血样本炎性因子及细胞因子检测

指标类型:

主要指标

Outcome:

Detection of inflammatory factors and cytokines in blood samples

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

性别

指标类型:

次要指标

Outcome:

Gender

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿常规

指标类型:

次要指标

Outcome:

urinalysis

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

便标本宏基因

指标类型:

主要指标

Outcome:

fecal sample metagenome

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心电图

指标类型:

次要指标

Outcome:

electrocardiogram

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血样本蛋白质组学

指标类型:

主要指标

Outcome:

Blood sample proteomics

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血样本水分子检测

指标类型:

主要指标

Outcome:

Detection of water molecules in blood samples

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体重指数 (BMI)

指标类型:

次要指标

Outcome:

Body Mass Index (BMI)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿微量白蛋白

指标类型:

次要指标

Outcome:

Urinary microalbumin

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

便标本蛋白组学

指标类型:

主要指标

Outcome:

proteomics of fecal samples

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血生化

指标类型:

主要指标

Outcome:

Blood biochemistry

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:

口腔

组织:

Sample Name:

oral cavity

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:

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:

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:

结束

Completed

年龄范围:

最小 18
Min age years
最大 75
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

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

N/A

盲法:

Blinding:

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):

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

N/A

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

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

Case Record Form, CRF

数据管理委员会:

Data Managemen Committee:

Yes

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):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above