ChiCTR2400081572 版本V1.0 版本创建时间2024/03/05 14:50:51 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：

ChiCTR2400081572 

最近更新日期：

Date of Last Refreshed on：

2024-03-05 14:50:46 

注册时间：

Date of Registration：

2024-03-05 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

医联体互动China-PAR评估及多学科团队管理对糖尿病患者心血管病风险的影响

Public title：

The impact of China PAR assessment and multidisciplinary team management on cardiovascular disease risk in type 2 diabetes

注册题目简写：

English Acronym：

研究课题的正式科学名称：

医联体互动China-PAR评估及多学科团队管理对糖尿病患者心血管病风险的影响

Scientific title：

The impact of China PAR assessment and multidisciplinary team management on cardiovascular disease risk in type 2 diabetes

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：

潘清蓉 

研究负责人：

潘清蓉 

Applicant：

Qingrong Pan 

Study leader：

Qingrong Pan 

申请注册联系人电话：

Applicant telephone：

+86 138 1081 5209

研究负责人电话：

Study leader's telephone：

+86 138 1081 5209

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：

panqingrongcn@163.com

研究负责人电子邮件：

Study leader's E-mail：

panqingrongcn@163.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：

北京市朝阳区工体南路8号

研究负责人通讯地址：

北京市朝阳区工体南路8号

Applicant address：

No. 8, Gongti South Road, Chaoyang District, Beijing

Study leader's address：

No. 8, Gongti South Road, Chaoyang District, Beijing

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：

首都医科大学附属北京朝阳医院

Applicant's institution：

Affiliated Beijing Chaoyang Hospital of Capital Medical University

研究负责人所在单位：

首都医科大学附属北京朝阳医院

Affiliation of the Leader：

Affiliated Beijing Chaoyang Hospital of Capital Medical University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2024-科-76

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：

首都医科大学附属北京朝阳医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Beijing Chaoyang Hospital Affiliated to Capital Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2024-02-05 00:00:00

伦理委员会联系人：

吕亚丽

Contact Name of the ethic committee：

Yali Lu

伦理委员会联系地址：

北京市朝阳区工体南路8号

Contact Address of the ethic committee：

No. 8, Gongti South Road, Chaoyang District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10 8523 1484

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

首都医科大学附属北京朝阳医院

Primary sponsor：

Affiliated Beijing Chaoyang Hospital of Capital Medical University

研究实施负责（组长）单位地址：

北京市朝阳区工体南路8号

Primary sponsor's address：

No. 8, Gongti South Road, Chaoyang 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(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

首都医科大学附属北京朝阳医院

具体地址：

北京市朝阳区工体南路8号

Institution
hospital：

Affiliated Beijing Chaoyang Hospital of Capital Medical University

Address：

No. 8, Gongti South Road, Chaoyang District, Beijing

经费或物资来源：

首都卫生发展科研专项经费（课题号：首发2023-2Y-007）

Source(s) of funding：

Supported by Capital health development research special fund (No.2023-2Y-007)

Target disease：

type 2 diabetes

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

评价医联体互动China-PAR评估+多学科团队管理干预与常规社区综合干预比较，对心血管病高风险糖尿病患者China-PAR评分、血糖管理及其他心血管风险因素的影响。  

Objectives of Study：

To assess the effects of medical alliance interactive China-PAR assessment + multidisciplinary team management intervention compared with conventional community comprehensive intervention on China-PAR score, blood glucose management and other cardiovascular risk factors in patients with diabetes at high risk of cardiovascular disease.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

a)符合糖尿病诊断标准，参考《中国2型糖尿病防治指南（2020版）》； b)年龄≥20岁，男性或女性； c)China-PAR风险评估心血管疾病10年风险≥ 10.0% d)签署知情同意书，自愿参与本研究。

Inclusion criteria

a) Meet the diagnostic criteria for diabetes, refer to the Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition); b) Age ≥ 20 years, male or female; c) China-PAR risk assessment 10-year risk ≥ 10.0% for cardiovascular disease d) Signed informed consent form to voluntarily participate in this study.

排除标准：

a)已经合并存在心血管疾病； b)妊娠或哺乳期妇女或1年内有妊娠计划的妇女； c)合并严重慢性疾病：如严重肾功能不全（估算肾小球滤过率＜30 ml/min/1.73m2）、肝病（活动性肝炎、失代偿性慢性肝病如肝硬化、腹水等）、严重血液系统疾病或恶性肿瘤等严重原发性疾病者； d)经过医生诊疗判断需转急性救治的患者； e)精神疾患、认知功能障碍及各种原因导致的患者无法配合随访。 f)存在主要研究者或研究医生认为排除的任何其他状况或事件者。

Exclusion criteria：

a) already have comorbid cardiovascular disease; b) pregnant or lactating women or women who have planned to conceive within 1 year; c) Patients with severe chronic diseases: such as severe renal insufficiency (estimated glomerular filtration rate <30 ml/min/1.73m2), liver disease (active hepatitis, decompensated chronic liver diseases such as liver cirrhosis, ascites, etc.), severe hematologic diseases or malignant tumors and other serious primary diseases; d) Patients who need to be transferred to acute treatment as judged by a doctor; e) Patients with mental disorders, cognitive dysfunction and various reasons are unable to cooperate with follow-up. f) Presence of any other condition or event that is excluded by the principal investigator or study physician in the opinion of the study physician.

研究实施时间：

Study execute time：

从 From 2024-01-01 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-03-11 00:00:00 至 To 2024-07-11 00:00:00  

干预措施：

Interventions：

组别：

干预组

样本量：

88

Group：

Intervention group

Sample size：

干预措施：

1）评估China-PAR心血管风险升高的原因：是否吸烟、是否血脂未达标，是否血压未达标，是否腰围、体重未达标，是否血糖未达标。 2）北京朝阳医院专家指导社区医生采取全方位干预措施： a.指导平衡膳食；保持食物多样性；同时控制总热量的摄入；不食用升糖指数高的食物，如甜食、粥类；每日盐摄入量控制在6g以内；限制饮酒；保证每天摄入300-500 g 蔬菜，对高胆固醇血症的高危人群，建议每日膳食胆固醇摄入小于300 mg，不建议饮酒。 b.运动指导:推荐健康成年人每周至少150 min 中等强度有氧身体活动，或每周至少75 min 高强度有氧身体活动，或相等量的两种强度活动的组合。同时做到个体化，量力而行，持之以恒。控制体重：以腰围男性＜90 cm 或女性＜85 cm，或体重指数＜24.0 kg/m2 为目标。 c.控制吸烟：戒烟专家对吸烟者提供戒烟建议，必要时考虑药物（酒石酸伐尼克兰）帮助下戒烟；对所有患者建议避免被动吸烟。 d.心内科医师指导降压、降血脂治疗，血压控制在＜130/80 mmHg，血脂控制目标LDL-C＜2.6 mmol/L，非HDL-C＜2.6mmol/L。LDL-C 达标后若甘油三酯仍高, 可在他汀治疗的基础上加用降低甘油三酯药物(如贝特类)。 e.内分泌科医师指导降糖治疗：根据患者年龄、职业、糖尿病病程、低血糖风险等制定个体化的降糖目标。对10年心血管风险评估结果为高危的糖尿病患者不论血糖是否达标，均建议给予GLP-1RA和/或SGLT2I，并给予阿司匹林(75-150mg/d)治疗。

干预措施代码：

Intervention：

1) Assess the reasons for the increase in cardiovascular risk in China-PAR: whether smoking, whether blood lipids are not up to standard, whether blood pressure is not up to standard, whether waist circumference and weight are not up to standard, and whether blood sugar is not up to standard. Experts from Beijing Chaoyang Hospital instructed community doctors to take a full range of interventions: a. Guide a balanced diet, maintain food diversity, control the total calorie intake, do not eat foods with high glycemic index, such as sweets and porridge, control the daily salt intake within 6g, limit alcohol consumption, ensure the daily intake of 300-500 g of vegetables, and for the high-risk groups of hypercholesterolemia, it is recommended that the daily dietary cholesterol intake is less than 300 mg, and it is not recommended to drink alcohol. b. Exercise guidance: It is recommended that healthy adults engage in at least 150 minutes of moderate-intensity aerobic physical activity per week, or at least 75 minutes of high-intensity aerobic physical activity per week, or an equivalent combination of the two intensities. At the same time, it is important to personalize the exercise routine, do what is manageable, and be consistent. Weight control: The goal should be a waist circumference of less than 90 cm for men or less than 85 cm for women, or a body mass index of less than 24.0 kg/m2. c. Smoking control: Smoking cessation specialists advise smokers to quit smoking, consider drugs (varenicline tartrate) to help them quit if necessary, and recommend avoiding passive smoking for all patients. d. The cardiologist guided the antihypertensive and hypolipidemic therapy, the blood pressure was controlled at <130/80 mmHg, and the target LDL-C < was 2.6 mmol/L, and the non-HDL-C < was 2.6 mmol/L. If triglycerides remain high after LDL-C is reached, triglyceride-lowering drugs (eg, fibrates) can be added to statin therapy. e. Endocrinologist to guide hypoglycemic therapy: Individualized hypoglycemic goals are formulated according to the patient's age, occupation, diabetes course, hypoglycemia risk, etc. GLP-1RA and/or SGLT2I and aspirin (75 to 150 mg/day) are recommended for patients with diabetes who are at high risk at 10 years, regardless of blood glucose targeting.

Intervention code：

组别：

对照组

样本量：

88

Group：

Control group

Sample size：

干预措施：

常规综合治疗及随访

干预措施代码：

Intervention：

Routine comprehensive treatment and follow-up

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)：

首都医科大学附属北京朝阳医院 

单位级别：

三甲 

Institution
hospital：

Affiliated Beijing Chaoyang Hospital of Capital Medical University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China 

Province：

Beijing 

City：

 

单位(医院)：

北京市朝阳区高碑店社区卫生服务中心 

单位级别：

社区卫生服务中心 

Institution
hospital：

Gaobeidian Community Health Service Center, Chaoyang District, Beijing

Level of the institution：

Community Health Service Center

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China 

Province：

Beijing 

City：

 

单位(医院)：

北京市朝阳区三里屯社区卫生服务中心 

单位级别：

社区卫生服务中心 

Institution
hospital：

Sanlitun Community Health Service Center, Chaoyang District, Beijing

Level of the institution：

Community Health Service Center

测量指标：

Outcomes：

指标中文名：

中国动脉粥样硬化性心血管疾病风险预测

指标类型：

主要指标

Outcome：

Prediction for ASCVD Risk in China, China-PAR

Type：

Primary indicator

测量时间点：

治疗前，入组后24周、48周

测量方法：

Measure time point of outcome：

Before treatment, 24 weeks and 48 weeks after enrollment

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：

治疗前，入组后24周、48周

测量方法：

Measure time point of outcome：

Before treatment, 24 weeks and 48 weeks after enrollment

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：

治疗前，入组后24周、48周

测量方法：

Measure time point of outcome：

Before treatment, 24 weeks and 48 weeks after enrollment

Measure method：

指标中文名：

尿白蛋白/肌酐

指标类型：

次要指标

Outcome：

Urinary albumin/creatinine ratio

Type：

Secondary indicator

测量时间点：

治疗前，入组后24周、48周

测量方法：

Measure time point of outcome：

Before treatment, 24 weeks and 48 weeks after enrollment

Measure method：

指标中文名：

低血糖

指标类型：

副作用指标

Outcome：

Hypoglycemia

Type：

Adverse events

测量时间点：

治疗前，入组后24周、48周

测量方法：

Measure time point of outcome：

Before treatment, 24 weeks and 48 weeks after enrollment

Measure method：

指标中文名：

空腹血糖，餐后2小时血糖

指标类型：

次要指标

Outcome：

blood sugar,2-hour postprandial blood glucose

Type：

Secondary indicator

测量时间点：

治疗前，入组后24周、48周

测量方法：

Measure time point of outcome：

Before treatment, 24 weeks and 48 weeks after enrollment

Measure method：

指标中文名：

血脂（总胆固醇、甘油三酯）

指标类型：

次要指标

Outcome：

Lipids (total cholesterol, triglycerides)

Type：

Secondary indicator

测量时间点：

治疗前，入组后24周、48周

测量方法：

Measure time point of outcome：

Before treatment, 24 weeks and 48 weeks after enrollment

Measure method：

指标中文名：

尿酸

指标类型：

次要指标

Outcome：

uric acid

Type：

Secondary indicator

测量时间点：

治疗前，入组后24周、48周

测量方法：

Measure time point of outcome：

Before treatment, 24 weeks and 48 weeks after enrollment

Measure method：

指标中文名：

同型半胱氨酸

指标类型：

主要指标

Outcome：

homocysteine

Type：

Primary indicator

测量时间点：

治疗前，入组后24周、48周

测量方法：

Measure time point of outcome：

Before treatment, 24 weeks and 48 weeks after enrollment

Measure method：

指标中文名：

肌酐

指标类型：

主要指标

Outcome：

creatinine

Type：

Primary indicator

测量时间点：

治疗前，入组后24周、48周

测量方法：

Measure time point of outcome：

Before treatment, 24 weeks and 48 weeks after enrollment

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

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：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 20 岁 years
最大 Max age 90 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）：

随机化及隐匿方法：由本项目的统计人员通过SAS version 9.10 软件产生随机码，并放入按顺序编码、密封、不透光的信封中，将入组患者随机分配成2组。

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

Randomization and concealment methods: The statisticians of this project generated random codes through SAS version 9.10 software, and put them into sequentially coded, sealed, and opaque envelopes, and randomly assigned the enrolled patients into two groups.

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：

由于两种措施（一种China-PAR模型评估＋个体化多学科团队管理，另一种常规综合治疗）存在明显差异，因此无法对研究者和受试者设盲，故为开放试验，但对数据统计分析人员设盲。

Blinding：

Due to the obvious differences between the two measures (one China-PAR model evaluation + individualized multidisciplinary team management, and the other conventional comprehensive treatment), it was impossible to blind the investigators and participants, so it was an open trial, but the data statistical analysts were blinded.

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

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）：

IPD可以通过邮箱向研究负责人获取

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

The IPD can be obtained from the study leader by email.

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）采用病案报告表（Case Report Forms，CRFs)收集数据:调查人员必须确保源文件中的所有信息与源信息一致。研究人员必须确认CRF上输入的信息完整且正确。研究监督员将把CRF的副本转交给本研究的统计中心。（2）数据管理：该数据库将由统计中心的专业统计人员建立和管理。EPIDATA软件（EPI 6.0）将用于输入数据。所有数据将由两名独立人员输入数据库，以进行双重检查。数据库不一致时，逐项核对原始记录表进行校对。由试验参与者在征得同意后由电子病案系统查阅相关患者信息，并向患者提供各种量表，全部过程中对患者信息及情况进行绝对保密保护。

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

(1) Data collection using Case Report Forms (CRFs) : Investigators must ensure that all information in source documents is consistent with source information. The researcher must confirm that the information entered on the CRF is complete and correct. Research supervisor will send a copy of the CRF over to this study of statistics. (2) Data management: The database will be established and managed by professional statisticians in the statistical Center. EPIDATA software (EPI 6.0) was used for data entry. All data will be used by two independent personnel to enter the database, to double check. When the database was inconsistent, the original record table was checked item by item for proofreading. Participants consulted relevant patient information from the electronic medical record system after obtaining consent, and provided patients with various scales, all of which were strictly confidential.

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：

  2024-03-05 14:50:46