今天是:2019-06-17 星期一

基于肠道菌群的化痰祛湿方调理痰湿体质防治糖尿病前期和血脂边缘升高的临床疗效和作用机制研究
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注册号:

Registration number:

ChiCTR1900020674 

最近更新日期:

Date of Last Refreshed on:

2019-01-12 

注册时间:

Date of Registration:

2019-01-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于肠道菌群的化痰祛湿方调理痰湿体质防治糖尿病前期和血脂边缘升高的临床疗效和作用机制研究 

Public title:

Gut Microbiota-Based Clinical Curative Effects and Mechanism Research of Preventive Treatment of Prediabetes and Borderline Hyperlipidemia by Adjusting Phlegm-dampness Constitution with Hua Tan Qu Shi Decoction 

注册题目简写:

 

English Acronym:

GUT-PD-BH-PDC 

研究课题的正式科学名称:

基于肠道菌群的化痰祛湿方调理痰湿体质防治糖尿病前期和血脂边缘升高的临床疗效和作用机制研究 

Scientific title:

Gut Microbiota-Based Clinical Curative Effects and Mechanism Research of Preventive Treatment of Prediabetes and Borderline Hyperlipidemia by Adjusting Phlegm-dampness Constitution with Hua Tan Qu Shi Decoction 

研究课题代号(代码):

Study subject ID:

国家自然科学基金重点项目(No. 81730112) 

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:

梁雪 

研究负责人:

王琦 

Applicant:

Liang Xue 

Study leader:

Wang Qi 

申请注册联系人电话:

Applicant telephone:

+86 18810900116 

研究负责人电话:

Study leader's telephone:

+86 13901003796 

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:

liangxue1888@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

wangqi710@126.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:

北京市朝阳区北三环东路11号北京中医药大学基础楼315 

研究负责人通讯地址:

北京市朝阳区北三环东路11号北京中医药大学逸夫科研楼503 

Applicant address:

Room 315, Preclinical Medicine Building, Beijing University of Chinese Medicine, 11 North Third Ring Road East, Chaoyang District, Beijing, China 

Study leader's address:

Room 503, Yifu Research Building, Beijing University of Chinese Medicine, 11 North Third Ring Road East, Chaoyang District, Beijing, China 

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:

100029 

申请人所在单位:

北京中医药大学 

Applicant's institution:

Beijing University of Chinese Medicine 

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:

2017BZHYLL0502 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

北京中医药大学医学与实验动物伦理委员会 

Name of the ethic committee:

The Medicine and Experimental Animal Ethics Committee of Beijing University of Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-09-19 

伦理委员会联系人:

赵燕 

Contact Name of the ethic committee:

Zhao Yan 

伦理委员会联系地址:

北京市朝阳区北三环东路11号北京中医药大学科技处 

Contact Address of the ethic committee:

Division of Science and Technology, Beijing University of Chinese Medicine, 11 North Third Ring Road East, Chaoyang District, Beijing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 15201484830 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

yanzh3232@126.com 

研究实施负责(组长)单位:

北京中医药大学 

Primary sponsor:

Beijing University of Chinese Medicine 

研究实施负责(组长)单位地址:

北京市朝阳区北三环东路11号北京中医药大学逸夫科研楼501 

Primary sponsor's address:

Room 501, Yifu Research Building, Beijing University of Chinese Medicine, 11 North Third Ring Road East, Chaoyang District, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京中医药大学中医体质与生殖医学研究中心

具体地址:

北京市朝阳区北三环东路11号

Institution
hospital:

Center for Studies in Constitution and Reproductive Sciences of Chinese Medicine, Beijing University of Chinese Medicine

Address:

11 North Third Ring Road East, Chaoyang District, Beijing, China

经费或物资来源:

国家自然科学基金重点项目(No. 81730112) 

Source(s) of funding:

Key Program of National Natural Science Foundation of China (No. 81730112) 

研究疾病:

糖尿病前期;血脂边缘升高 

Target disease:

prediabetes; borderline hyperlipidemia 

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:

探索性研究/预试验 

Study phase:

研究目的:

1.总体目标:评估化痰祛湿方改善痰湿体质偏颇以及通过调理痰湿体质防治糖尿病前期和血脂边缘升高的临床疗效和改善肠道菌群的效果,研究临床疗效、体质偏颇和肠道菌群改善之间的相关性,揭示肠道菌群参与调体防治糖尿病前期和血脂边缘升高的作用机制。 2.具体目标:2.1临床研究目标:分析宿主体质与糖脂代谢指标的特征变化规律,观察化痰祛湿方改善痰湿体质偏颇以及通过调理痰湿体质防治糖尿病前期和血脂边缘升高的临床疗效,为建立以肠道菌群为靶点的中药调整痰湿体质防治多种代谢疾病干预方案提供方法和证据。2.2机制研究目标:2.2.1分析宿主体质、糖脂代谢指标、肠道菌群结构的共变化趋势,探讨化痰祛湿方临床疗效和肠道菌群结构改善之间的相关性;2.2.2分析肠道菌群功能基因及代谢路径与宿主代谢指标、代谢产物的关系,揭示肠道菌群参与化痰祛湿方改善痰湿体质偏颇和防治糖脂代谢疾病前期的作用机制。 

Objectives of Study:

1. Overall Objectives: To evaluate the curative effects, the constitutional bias improvements and the gut microbiota modulation achievements of Hua Tan Qu Shi decoction for phlegm-dampness constitution, phlegm-dampness constitution with prediabetes and phlegm-dampness constitution with borderline hyperlipidemia. To discover the correlation among curative effects, constitutional bias improvements and gut microbiota modulation. To reveal the mechanism of preventive treatment of prediabetes and borderline hyperlipidemia by adjusting phlegm-dampness constitution with Hua Tan Qu Shi decoction. 2. Detailed Research Objectives: 2.1 Clinical Research Objectives: To analyze the characteristic variation patterns of the host constitution, glucose and lipid metabolism indicators, observe the curative effects, the constitutional bias improvements and the gut microbiota modulation achievements and provide a new way and evidence for the establishment of an effective gut microbiota-targeted clinical intervention projects by adjusting phlegm-dampness constitution with Chinese medicine. 2.2 Mechanism Research Objectives: 2.2.1 To analyze the characteristic variation patterns of the host constitution, glucose and lipid metabolism indicators, and the gut microbiota composition during the intervention process and discover the correlation among curative effects, constitutional bias improvements and gut microbiota modulation. 2.2.2 To study the relationship of the gut microbiota functional genes together with their metabolic pathway, host metabolism indicators and metabolites during the intervention process and investigate the mechanism of the role of gut microbiota in preventive treatment process of prediabetes and borderline hyperlipidemia by adjusting phlegm-dampness constitution with Hua Tan Qu Shi decoction. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1.按照研究诊断标准,体质判定为平和体质健康人群或单纯痰湿体质人群,疾病诊断为糖尿病前期或血脂边缘升高人群; 2.年龄范围:18岁≤年龄<45岁(年龄按照筛选调查日期与出生日期的差值计算);性别不限; 3.汉族,在北京居住至少5年,有固定住所; 4.平和体质人群:18.5≤体重指数(BMI)<24;痰湿体质人群:体重指数(BMI)≥24; 5.具有良好的记忆和活动能力,生活能够自理,心理健康; 6.受试者知情同意,并签署知情同意书; 7.较好依从性者:尽量保证不出差、不在外用餐、作息时间规律、饮食摄入规律、充足的时间参与本项目,对改变自己身体状况具有迫切愿望并且充分理解“中药调体防治代谢疾病”和“慢性病的肠源性学说”; 8.目前并且在研究开始后的4个月内没有参加其他研究项目。 

Inclusion criteria

1. Classified balance constitution and phlegm-dampness constitution according to the China Association of Chinese Medicine (CACM) standards 2009 (Classification and Determination of Constitution in Traditional Chinese Medicine, No:ZZYXH/T157-2009). Diagnosed prediabetes patients according to Chinese Diabetes Society (CDS) standards 2017 (China Guideline for Type 2 Diabetes). Diagnosed borderline hyperlipidemia patients according to Joint Committee on Revision of China Guideline for Prevention and Treatment of Adult Hyperlipidemia (National Center for Cardiovascular Diseases,NCCD/Chinese Society of Cardiology,CSC/Chinese Diabetes Society,CDS/Chinese Society of Endocrinology, CSE/Chinese Society of Laboratory Medicine, CSLM) standards 2016 (China Guideline for Prevention and Treatment of Adult Hyperlipidemia (2016 Revision)); 2. Aged 18-45 years old male and female; 3. Han population living in the local more than five years and having constant residence; 4. BMI of balance constitution should range from 18.5 to 24. BMI of phlegm-dampness constitution should not less than 24; 5. Having good memory, motility, self-care ability and healty mentality; 6. Agreeing to join the study and signing the informed consent; 7. Having good compliance: no business trips, no outdoor dining, regular work and rest time, regular dietary intake, adequate time to participate in this study, having a burning desire to change physical condition, fully understanding of 'preventive treatment of metabolic diseases by adjusting phlegm-dampness constitution with Chinese Medicine decoctions' and 'enterogenous theory of chronic diseases'; 8. Having not attend any other research projects currently or in 4 months after join this research. 

排除标准:

1.过去3个月内使用过抗生素;过去3个月内使用胃肠动力药、微生态调节剂等其它影响肠道菌群状况的食物和药物; 2.过去3个月内以任何药物方法(包括氟苯丙氨等食欲抑制剂类药物、甲状腺激素、孕酮、泻剂等和各种中药成分减肥药)或手术方式进行减肥者; 3.过去3个月内因下列疾病接受药物治疗:胆囊炎、消化道溃疡、尿路感染、急性肾盂肾炎、膀胱炎、甲亢等甲状腺功能异常; 4.计划怀孕、妊娠期、哺乳期妇女,绝经期妇女(冠心病高风险人群); 5.酗酒(1周饮酒5次以上,平均每次2两白酒、半斤黄酒或2500毫升啤酒以上); 6.进行过胃肠道手术,除阑尾炎、疝气手术外; 7.患有精神疾患; 8.患有严重的心、肝、脑、肺、肾、血液疾病,如癌症、冠心病、心肌梗塞以及脑卒中等,非酒精性脂肪肝除外; 9.患有慢性迁延性肝炎、肝硬化等严重肝脏疾病患者或乙肝病毒表面抗原(HBsAg)阳性并伴随有肝功能有异常者(血清谷丙转氨酶和谷草转氨酶是正常值的2.5倍); 10.患有IBD、库兴综合征、垂体功能异常; 11.患有肺结核、艾滋病等传染病。 

Exclusion criteria:

1. Antibiotic usage in last 3 months. Other foods or drugs affecting intestinal flora usage in last 3 months, e.g. gastrointestinal prokinetic agents, micro-ecological modulators; 2. Received weight-loss drugs or surgical methods therapy in last 3 months, e.g. appetite inhibitors fluorophenylalamide, thyroid hormones, progesterone, laxatives and traditional Chinese medicine ingredients for weight loss; 3. Received drug therapy aim at the following diseases, e.g. cholecystitis, peptic ulcer, urinary tract infection, acute pyelonephritis, urocystitis or hyperthyreosis; 4. Pregnancy, planning to become pregnant, lactation or menopausal women (high risk population of coronary heart disease); 5. Excessive drinking (drinking more than 5 times in one week and drinking more than 100g white liquor, 250g yellow rice wine or 2500ml of beer); 6. Received gastrointestinal surgery except for appendicitis or hernia surgery; 7. With mental diseases; 8. With other severe diseases in heart, liver, brain, lung, kidney or blood, e.g. cancer, coronary heart disease, myocardial infarction and cerebral apoplexy, except for nonalcohol fatty liver disease; 9. With chronic persistent hepatitis, severe hepatic diseases, e.g. liver cirrhosis or cooccurence of positive HBsAg and abnormal hepatic transaminase; 10. With IBD, Cushing's syndrome or pituitary dysfunction; 11. With infectious disease, e.g. phthisis and AIDS. 

研究实施时间:

Study execute time:

From2019-01-01To 2019-01-01 

干预措施:

Interventions:

组别:

平和体质组

样本量:

50

Group:

balance constitution (BC)

Sample size:

干预措施:

干预措施代码:

Intervention:

without

Intervention code:

组别:

痰湿体质干预组

样本量:

50

Group:

phlegm-dampness constitution 1 (PDC1)

Sample size:

干预措施:

化痰祛湿方+常规饮食指导

干预措施代码:

Intervention:

Hua Tan Qu Shi decoction + routine diet guidance

Intervention code:

组别:

痰湿体质对照组

样本量:

50

Group:

phlegm-dampness constitution 2 (PDC2)

Sample size:

干预措施:

安慰剂+常规饮食指导

干预措施代码:

Intervention:

placebo + routine diet guidance

Intervention code:

组别:

痰湿体质兼有糖尿病前期干预组

样本量:

50

Group:

phlegm-dampness constitution with prediabetes 1 (PDCD1)

Sample size:

干预措施:

化痰祛湿方+常规饮食指导

干预措施代码:

Intervention:

Hua Tan Qu Shi decoction + routine diet guidance

Intervention code:

组别:

痰湿体质兼有糖尿病前期对照组

样本量:

50

Group:

phlegm-dampness constitution with prediabetes 2 (PDCD2)

Sample size:

干预措施:

安慰剂+常规饮食指导

干预措施代码:

Intervention:

placebo + routine diet guidance

Intervention code:

组别:

痰湿体质兼有血脂边缘升高干预组

样本量:

50

Group:

phlegm-dampness constitution with borderline hyperlipidemia 1 (PDCH1)

Sample size:

干预措施:

化痰祛湿方+常规饮食指导

干预措施代码:

Intervention:

Hua Tan Qu Shi decoction + routine diet guidance

Intervention code:

组别:

痰湿体质兼有血脂边缘升高对照组

样本量:

50

Group:

phlegm-dampness constitution with borderline hyperlipidemia 2 (PDCH2)

Sample size:

干预措施:

安慰剂+常规饮食指导

干预措施代码:

Intervention:

placebo + routine diet guidance

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京中医药大学 

单位级别:

大学 

Institution
hospital:

Beijing University of Chinese Medicine  

Level of the institution:

University 

测量指标:

Outcomes:

指标中文名:

中医体质量表得分

指标类型:

主要指标 

Outcome:

Score of Chinese Medicine Constitution Scale

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

空腹血糖

指标类型:

主要指标 

Outcome:

FPG

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2小时血糖

指标类型:

主要指标 

Outcome:

2hPG

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:

主要指标 

Outcome:

TG

Type:

Primary 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:

主要指标 

Outcome:

TC

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

低密度脂蛋白胆固醇

指标类型:

主要指标 

Outcome:

LDL-C

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

高密度脂蛋白胆固醇

指标类型:

主要指标 

Outcome:

HDL-C

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:

次要指标 

Outcome:

HbA1c

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

空腹胰岛素

指标类型:

次要指标 

Outcome:

FINS

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

餐后2小时胰岛素

指标类型:

次要指标 

Outcome:

INS

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

载脂蛋白α

指标类型:

次要指标 

Outcome:

Apo-α

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

载脂蛋白β

指标类型:

次要指标 

Outcome:

Apo-β

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体重

指标类型:

次要指标 

Outcome:

Weight

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体脂率

指标类型:

次要指标 

Outcome:

Body Fat Percentage

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血压

指标类型:

次要指标 

Outcome:

Blood Pressure

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

腰围

指标类型:

次要指标 

Outcome:

Waistline

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

臀围

指标类型:

次要指标 

Outcome:

Hipline

Type:

Secondary 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

指标类型:

次要指标 

Outcome:

W/H

Type:

Secondary 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

指标类型:

次要指标 

Outcome:

Body Mass Index

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:

次要指标 

Outcome:

HOMA-IR Index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胰岛素敏感指数

指标类型:

次要指标 

Outcome:

Insulin Sensitivity Index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肠泌肽

指标类型:

次要指标 

Outcome:

Intestinal Secretion Peptide

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

炎症因子

指标类型:

次要指标 

Outcome:

Inflammatory Factor

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

内毒素

指标类型:

次要指标 

Outcome:

LPS

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肠道菌群结构测定

指标类型:

次要指标 

Outcome:

The composition of gut microbiota

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肠道菌群功能测定

指标类型:

次要指标 

Outcome:

The function of gut microbiota

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肠道菌群代谢

指标类型:

次要指标 

Outcome:

The metabolism of gut microbiota

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

高血糖和低血糖事件

指标类型:

副作用指标 

Outcome:

Hyperglycemia and hypoglycemia events

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良事件发生率

指标类型:

副作用指标 

Outcome:

Adverse Event Rate

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝功能

指标类型:

附加指标 

Outcome:

liver function

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肾功能

指标类型:

附加指标 

Outcome:

kidney function

Type:

Additional 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/尿液/粪便

组织:

Sample Name:

Blood/Urine/Faces

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 years
最大 Max age 45 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):

试验者使用随机数字表

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

table of random number by experimenter

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

2020年,公开方式为论文发表

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

In 2020. Publication of paper is the way of sharing.

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:

由病例记录表记录数据,由ResMan平台进行电子数据采集和管理

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

Case Record Form (CRF) is used for data recording and ResMan is used for data management.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-01-12
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