Randomized controlled clinical study on treating type 2 diabetes mellitus with nonalcoholic fatty liver with Jiangtang Xiaozhi prescription

注册号:

Registration number:

ITMCTR2024000294

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:

降糖消脂方治疗2型糖尿病合并非酒精性脂肪肝的临床随机对照研究

Public title:

Randomized controlled clinical study on treating type 2 diabetes mellitus with nonalcoholic fatty liver with Jiangtang Xiaozhi prescription

注册题目简写:

English Acronym:

研究课题的正式科学名称:

降糖消脂方治疗2型糖尿病合并非酒精性脂肪肝的临床随机对照研究

Scientific title:

Randomized controlled clinical study on treating type 2 diabetes mellitus with nonalcoholic fatty liver with Jiangtang Xiaozhi prescription

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:

刘龑姣

研究负责人:

陈筑红

Applicant:

Liu Yanjiao

Study leader:

Chen Zhuhong

申请注册联系人电话:

Applicant telephone:

17812001695

研究负责人电话:

Study leader's telephone:

13264214919

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:

lyj1755917648@163.com

研究负责人电子邮件:

Study leader's E-mail:

13264214919@163.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:

北京市海淀区西苑操场1号

研究负责人通讯地址:

北京市海淀区西苑操场1号

Applicant address:

No. 1 Xiyuan Playground Haidian District Beijing

Study leader's address:

No. 1 Xiyuan Playground Haidian 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:

100029

申请人所在单位:

中国中医科学院西苑医院

Applicant's institution:

Xi Yuan Hospital of Academy of Chinese Medical Sciences

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:

中国中医科学院西苑医院医学伦理委员会2024XLA107-2

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:

中国中医科学院西苑医院医学伦理委员会

Name of the ethic committee:

EC of Xi Yuan Hospital of Academy of Chinese Medical Sciences

伦理委员会批准日期:

Date of approved by ethic committee:

2024/7/4 0:00:00

伦理委员会联系人:

訾明杰

Contact Name of the ethic committee:

Zi Mingjie

伦理委员会联系地址:

北京市海淀区西苑操场1号

Contact Address of the ethic committee:

No. 1 Xiyuan Playground Haidian District Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

010-62835646

伦理委员会联系人邮箱:

Contact email of the ethic committee:

xiyuanlunli@163.com

研究实施负责(组长)单位:

中国中医科学院西苑医院

Primary sponsor:

Xi Yuan Hospital of Academy of Chinese Medical Sciences

研究实施负责(组长)单位地址:

北京市海淀区西苑操场1号

Primary sponsor's address:

No. 1 Xiyuan Playground Haidian 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):

朝阳区

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院西苑医院

具体地址:

北京市海淀区西苑操场1号

Institution
hospital:

Xi Yuan Hospital of Academy of Chinese Medical Sciences

Address:

No. 1 Xiyuan Playground Haidian District Beijing

经费或物资来源:

2023年度中华中医药学会青年求实项目

Source(s) of funding:

China Association of Chinese Medicine

研究疾病:

2型糖尿病合并非酒精性脂肪肝

研究疾病代码:

Target disease:

Type 2 diabetes mellitus with nonalcoholic fatty liver disease

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:

1.通过开展随机、安慰剂对照探索性研究,验证降糖消脂方治疗T2DM合并NAFLD的疗效及安全性,为获得临床试验批件、开展Ⅱ期、Ⅲ期临床试验提供依据。 2.初步分析降糖消脂方治疗T2DM合并NAFLD的作用机制。

Objectives of Study:

1. A randomized placebo-controlled exploratory study was conducted to verify the efficacy and safety of Jiangtang Xiaozhi prescription in the treatment of T2DM complicated with NAFLD and to provide evidence for obtaining clinical trial approval and carrying out phase II and III clinical trials. 2. To analyze the mechanism of Jiangtang Xiaozhi prescription in treating T2DM with NAFLD.

药物成份或治疗方案详述:

1、基础治疗:试验组及对照组均给予基础治疗,基础治疗:饮食推荐中等程度的热量限制,肥胖成人每日热量摄入需减少300-500千卡;改变饮食组分、建议低糖低脂的平衡膳食,减少含蔗糖饮料以及饱和脂肪酸及反式脂肪酸的摄入,采用脂肪肝的标准饮食及运动(每天脂肪摄入量低于总热卡的25%,不饮酒或每周酒精摄入量低于40g);运动:中等量有氧运动,每周4次以上,累计锻炼时间至少150min;维持原有降糖方案:目标血糖控制:空腹血糖≤7mmol/L,餐后2h血糖≤10mmol/L。停服中药或中成药,2周后导入期后入组。 2、药物:降糖消脂方颗粒剂(颗粒剂,每袋5克,含生药18克,由我院院制剂室提供),安慰剂(颗粒剂,每袋5克,不含生药,由我院院制剂室提供)。 3、剂量:试验组:口服降糖消脂方颗粒剂每次1袋,每天2次;对照组:口服安慰剂,每次1袋,每天2次。 4、疗程:12周。 5、 合并用药及合并治疗: ① 合并用药:所有试验病例在试验期间不得合并使用补气健脾,活血祛瘀,化痰除湿作用的中药,或具有类似作用的中药。不得加用有降脂作用的西药,既往降脂药物服用稳定4周以上者,可保持剂量不变继续应用,不得服用可能影响本研究疗效观察的药物(胰岛素增敏剂、减肥药、甘利欣、肝炎灵、多不饱和卵磷脂、还原型谷胱甘肽、激素等),所有药物的应用均应详细记录在合并用药记录表中。② 合并治疗:合并其它疾病所必须继续服用的药物,可继续服用,所用的药物或其他治疗方法必须在格式病案记录药名(或其它疗法名)、用量、使用次数和时间等,以便总结时加以分析和报告。

Description for medicine or protocol of treatment in detail:

1.Primary therapy for both experimental group and control group. Moderate dietary caloric restriction is recommended and obese adults need to reduce their daily caloric intake by 300-500 kcal. Change the composition of the diet recommend a balanced diet with low sugar and fat reduce the intake of sucrose beverages and saturated fatty acids and trans fatty acids adopt the standard diet and exercise for fatty liver (fat intake is less than 25% of the total caloric calories per day no alcohol or alcohol intake is less than 40g per week Exercise: Moderate aerobic exercise more than 4 times a week the cumulative exercise time of at least 150 minutes Maintain the original hypoglycemic program: Target blood glucose control: fasting blood glucose ≤7mmol/L 2h postprandial blood glucose ≤10mmol/L. Stop taking Chinese medicine or proprietary Chinese medicine and enter the group after the introduction period 2 weeks later. 2. Medicine: Jiangtang Xiaozhi granules( Granule 5 g per bag containing 18 g crude drug provided by the preparation Department of our hospital); placebo( Granule 5 g per bag without crude drug provided by the preparation Department of our hospital ). 3. Dosage: Trial group: oral Jiangtang Xiaozhi Fang granule 1 bag each time twice a day; Control group: Oral placebo 1 bag each time 2 times a day. 4. Duration: 12 weeks. 5. Combination medication and combination therapy: Combination medication: During the trial period all the test cases should not be combined with the traditional Chinese medicine of invigorating qi and strengthening spleen promoting blood circulation and removing blood stasis resolving phlegm and removing dampness or with similar effects. Western drugs with lipid-lowering effects are not allowed to be added. Those who have been taking lipid-lowering drugs for more than 4 weeks can keep the dose unchanged and continue to use them. Drugs that may affect the curative effect of this study (insulin sensitizer diet drug gamlixin hepatitis alin polyunsaturated lecithin reduced glutathione hormones etc.) are not allowed. The use of all medications should be recorded in detail in the combined medication record sheet. combination therapy: Drugs that must continue to be taken in combination with other diseases can continue to be taken and the drugs or other treatment methods used must be recorded in the form of medical records such as the name of the drug (or other therapy name) dosage frequency and time of use so as to be analyzed and reported in the summary.

纳入标准:

(1)符合西医T2DM合并NAFLD诊断标准,NAFLD疾病谱较广,包括非酒精性单纯性肝脂肪变(NAFL)、非酒精性脂肪性肝炎(NASH)、及NASH相关肝硬化和肝细胞癌(HCC),本研究纳入NAFLD具体进展阶段人群为非酒精性单纯性脂肪肝变(NAFL),肝脏B超符合脂肪肝的影像诊断,以及中医辨证属气虚痰瘀证的患者。 (2)年龄在 18—65 岁之间,性别不限; (3)受试者知情,自愿签署知情同意书; (4)血糖水平:糖化血红蛋白<8.5%,FBG<10mmol/l, PBG<13mmol/l。

Inclusion criteria

1.It meets the diagnostic criteria of Western medicine for T2DM combined with NAFLD and has a wide spectrum of NAFLD diseases including non-alcoholic simple hepatic steatosis (NAFL) non-alcoholic steatohepatitis (NASH) NASH-related cirrhosis and hepatocellular carcinoma (HCC). In this study patients with non-alcoholic simple fatty liver degeneration (NAFL) at specific stages of NAFLD were included patients with liver B-ultrasound consistent with image diagnosis of fatty liver and patients with TCM syndrome differentiation of Qi deficiency and phlegm stasis. 2. Age 18-65 years old gender is not limited. 3. Subjects are informed and sign informed consent voluntarily. 4. Blood glucose level: HBA1c <8.5% FBG<10mmol/l PBG<13mmol/l.

排除标准:

(1)肝功能明显异常(ALT 或 AST>正常上限 2 倍以上);近 1 个月来加用其他保肝、降酶药而影响疗效评价者; (2)肝纤维化、肝硬化、肝实体肿瘤、以及局灶性脂肪肝不能排除再生结节或转移瘤者;能够导致脂肪肝其他的肝脏疾病,自身免疫性肝病(Autoimmune liver disease)、药物性肝损伤(DILI)等; (3)糖尿病应用 GLP-1,SGLT-2,TZD 类降糖药物者; (4)在随机化前 3 个月内使用非稳定剂量的他汀类或贝特类药物者; (5)近三个月发生过糖尿病急性并发症; (6)合并心、肺、肾等重要脏器严重器质性疾病或造血系统严重疾病,肿瘤、严重心脑血管疾病、精神病患者; (7)肾功能异常者; (8)妊娠或准备妊娠妇女,哺乳期妇女; (9)对本研究药物过敏者; (10)无法进行本研究中涉及到的检查及检验; 不能合作或正在参加其他临床试验者。

Exclusion criteria:

1. Significantly abnormal liver function (ALT or AST> 2 times the upper limit of normal); In the past 1 month the use of other liver protection and enzyme lowering drugs affected the efficacy evaluation. 2. Liver fibrosis cirrhosis solid liver tumors and focal fatty liver can not exclude regenerated nodules or metastases; It can lead to fatty liver and other liver diseases which are Autoimmune liver disease and drug-induced liver injury (DILI). 3. Diabetes patients with GLP-1SGLT-2 TZD hypoglycemic drugs. 4. Non-stable doses of statins or Bates in the 3 months prior to randomization. 5. Acute complications of diabetes occurred in the past three months. 6. Patients with serious organic diseases of the heart lung kidney and other important organs or serious diseases of the hematopoietic system tumors serious cardiovascular and cerebrovascular diseases and mental disorders. 7. Patients with abnormal renal function. 8. Women who are pregnant or trying to become pregnant breastfeeding women. 9. Patients with drug allergy in this study. 10. The examinations and tests involved in this study could not be performed. Those who cannot cooperate or are participating in other clinical trials.

研究实施时间:

Study execute time:

From 2024-08-28

To      2026-12-31

征募观察对象时间:

Recruiting time:

From 2024-08-28

To      2026-12-31

干预措施:

Interventions:

组别:

试验组

样本量:

72

Group:

experimental group

Sample size:

干预措施:

口服降糖消脂方颗粒剂每次1袋,每天2次

干预措施代码:

Intervention:

Oral Jiangtang Xiaozhi granules

Intervention code:

组别:

对照组

样本量:

72

Group:

control group 1 bag twice a day

Sample size:

干预措施:

口服安慰剂,每次1袋,每天2次

干预措施代码:

Intervention:

Oral placebo 1 bag twice a day

Intervention code:

样本总量 Total sample size : 144

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):

海淀区

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院西苑医院

单位级别:

局级

Institution/hospital:

Xi Yuan Hospital of Academy of Chinese Medical Sciences

Level of the institution:

Bureau level

测量指标:

Outcomes:

指标中文名:

肾功能

指标类型:

副作用指标

Outcome:

renal function

Type:

Adverse events

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:

副作用指标

Outcome:

Routine urine examination

Type:

Adverse events

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:

次要指标

Outcome:

Blood glucose

Type:

Secondary indicator

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:

次要指标

Outcome:

Liver function

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心电图

指标类型:

副作用指标

Outcome:

electrocardiogram

Type:

Adverse events

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

指标类型:

次要指标

Outcome:

insulin

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:

次要指标

Outcome:

Glycosylated hemoglobin

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:

Insulin resistance 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:

血脂

指标类型:

次要指标

Outcome:

Blood lipid

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

便常规

指标类型:

副作用指标

Outcome:

Stool routine

Type:

Adverse events

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:

副作用指标

Outcome:

Blood routine examination

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肿瘤坏死因子-α

指标类型:

次要指标

Outcome:

TNF-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:

超敏C反应蛋白

指标类型:

次要指标

Outcome:

hs-CRP

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:

肝脏B超超声声衰减系数较基线变化

指标类型:

主要指标

Outcome:

Liver B ultrasonic sound attenuation coefficient

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:

粪便

组织:

Sample Name:

stool

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:

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:

尚未开始

Not yet recruiting

年龄范围:

最小 18
Min age years
最大 65
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):

采用 SPSS 统计软件生成随机数字表,根据随机数字表将对应的分组代码装入信 封,由与本试验无关的医务人员控制分配方案,注意隐藏随机方法; 临床医师按顺序号拆开信封,根据其中的分组代码,以 1:1 的比例依次将患者分别纳入不同的处理组。盲法设计:本次试验受试者方和研究者方对受试者的治疗分组信息均处于盲态。使用连续编号的不透明信封进行盲法,每个信封中都包含一张说明试验药物编号的折叠纸,并由独立研究人员在远离医院的实验室中存储和打开,打开信封后,组分配未更改。

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

SPSS statistical software was used to generate a random number table. According to the random number table the corresponding grouping code was loaded into the envelope. Medical personnel unrelated to this experiment controlled the distribution scheme and paid attention to hiding the random method. The clinician opened the envelope according to the sequence number and placed the patients into different treatment groups in a 1:1 ratio according to the group code. Blind design: In this experiment both the subject and the investigator were blind in the treatment group information of the subjects. The blind method was performed using consecutively numbered opaque envelopes each containing a folded piece of paper stating the trial drug number and stored and opened by an independent researcher in a laboratory away from the hospital with group assignments unchanged after opening the envelopes.

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):

不共享原始数据。

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

Raw data is not 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:

(1)数据采集: 研究者记录所有项目均需填写,不得空项、漏项(无记录的空格划斜线),做任何更正时只能划斜线,旁注改后的数据,说明理由,由研究者签名并注明日期,不得涂擦,覆盖原始记录。 研究病历完成观察后3天内将研究记录等资料交研究质控负责人审核。 (2)数据录入 应用excel构建数据库,所有数据采用网上录入方式,由研究负责单位指定2 名研究员录入数据,交叉审核。 (3)数据资料的存档规定 本研究结束后,所有临床研究相关文件均需归档。所有纸质和电子文件均需要妥善保存,及时交档案管理人员。 纸质文件主要为数据管理计划,研究病历接收清单,数据录入清单等;电子文件主要包括以上内容的电子邮件,网上填表的数据库,用于统计的数据库,双份录入不一致清单,数据修正清单,往来电子邮件,研究进程报告等。所有电子文件均妥善保存。档案管理员完成归档文件接受,并以临床数据档案项目清单确认。

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

1. Data acquisition All items recorded by the researcher should be filled in no empty items missing items (no record of the space slash) make any correction can only slash note the changed data explain the reason signed and dated by the researcher shall not be erased covering the original record. Within 3 days after the completion of the study medical records the study records and other materials will be submitted to the research quality control person for review. 2. Data entry Excel was used to build the database and all data were entered online. Two researchers were designated by the research unit to enter the data and cross-review the data. 3. Requirements for archiving data After the end of this study all clinical study related documents should be filed. All paper and electronic documents need to be properly stored and promptly submitted to the records manager. The paper documents are mainly data management plan research medical record receiving list data entry list etc. Electronic documents mainly include the above contents of E-mail online form filling database database for statistics double entry inconsistencies list data correction list E-mail exchanges research progress reports etc. All electronic documents are securely stored. The archivist completes the acceptance of archived documents and confirms them with a list of clinical data file items.

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