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Which score to predict diabetes remission?
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注册号:

Registration number:

ChiCTR2100043429 

最近更新日期:

Date of Last Refreshed on:

2021-06-06 

注册时间:

Date of Registration:

2021-02-17 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

Which score to predict diabetes remission? 

Public title:

Which score to predict diabetes remission? 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

Predicting diabetes remission after bariatric surgery: Which score should we use? 

Scientific title:

Predicting diabetes remission after bariatric surgery: Which score should we use? 

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:

Izabela Karpińska 

研究负责人:

Prof. Piotr Major 

Applicant:

Izabela Karpińska 

Study leader:

Prof. Piotr Major 

申请注册联系人电话:

Applicant telephone:

+48 510710066 

研究负责人电话:

Study leader's telephone:

+48 12 400 26 01 

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:

iza.karpinska@interia.pl 

研究负责人电子邮件:

Study leader's E-mail:

piotr.major@uj.edu.pl 

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:

Jakubowskiego 2 st., 30-688, Kraków, Poland;  

研究负责人通讯地址:

Jakubowskiego 2 st., 30-688, Kraków, Poland;  

Applicant address:

Jakubowskiego 2 st., 30-688, Kraków, Poland;  

Study leader's address:

Jakubowskiego 2 st., 30-688, Kraków, Poland;  

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:

波兰2nd Department of General Surgery, Jagiellonian University Medical College, Kraków, Poland. 

Applicant's institution:

2nd Department of General Surgery, Jagiellonian University Medical College, Kraków, Poland. 

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:

122/6120/5/2017 

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:

The independent ethics committee of the Jagiellonian University 

Name of the ethic committee:

The independent ethics committee of the Jagiellonian University 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-04-28 

伦理委员会联系人:

The independent ethics committee of the Jagiellonian University 

Contact Name of the ethic committee:

The independent ethics committee of the Jagiellonian University 

伦理委员会联系地址:

8 Skawińska st. 31-066 Kraków, Poland 

Contact Address of the ethic committee:

8 Skawińska st. 31-066 Kraków, Poland 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

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:

The study required no funding 

Primary sponsor:

The study required no funding 

研究实施负责(组长)单位地址:

not applicable 

Primary sponsor's address:

not applicable 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

The study required no funding 

Source(s) of funding:

The study required no funding 

研究疾病:

diabetes 

Target disease:

diabetes 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

To validate the performance of available risk prediction scores for diabetes remission 1 year after surgical treatment and determine optimal model. 

Objectives of Study:

To validate the performance of available risk prediction scores for diabetes remission 1 year after surgical treatment and determine optimal model. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

We included consecutive patients with T2DM who underwent bariatric surgery, eighter laparoscopic sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB) in our hospital and completed 1 year of postoperative follow-up. 

Inclusion criteria

We included consecutive patients with T2DM who underwent bariatric surgery, eighter laparoscopic sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB) in our hospital and completed 1 year of postoperative follow-up. 

排除标准:

Patients with already existing severe complications of T2DM, type 1 diabetes mellitus as well as history of bariatric surgery and those who were qualified for reoperation were excluded from the study. 

Exclusion criteria:

Patients with already existing severe complications of T2DM, type 1 diabetes mellitus as well as history of bariatric surgery and those who were qualified for reoperation were excluded from the study. 

研究实施时间:

Study execute time:

From2019-10-22To 2020-06-10 

征募观察对象时间:

Recruiting time:

From2009-04-01To 2017-10-31 

干预措施:

Interventions:

组别:

Case series

样本量:

252

Group:

Case series

Sample size:

干预措施:

laparoscopic sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB)

干预措施代码:

Intervention:

laparoscopic sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB)

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

Poland 

省(直辖市):

maopolska 

市(区县):

Kraków 

Country:

Poland 

Province:

maopolska 

City:

Kraków 

单位(医院):

Kraków University Hospital, Kraków, Poland 

单位级别:

University Hospital 

Institution
hospital:

Kraków University Hospital, Kraków, Poland  

Level of the institution:

University Hospital 

测量指标:

Outcomes:

指标中文名:

diabetes remission

指标类型:

主要指标 

Outcome:

diabetes remission

Type:

Primary indicator 

测量时间点:

1 year

测量方法:

Measure time point of outcome:

1 year

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

blood

组织:

Sample Name:

blood

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 68 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):

As the design of the study is retrospective and comprises only one group, the randomization procedure was not required.

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

No

盲法:

N/A

Blinding:

N/A

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):

electronical

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

electronical

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:

Data collection and data management were done electronically.

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

Data collection and data management were done electronically.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2021-02-17
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