Insulin resistance and vitamin D deficiency are frequently seen in diabetic patients. Vitamin D deficiency can have a negative effect on blood glucose level and weight loss.

注册号:

Registration number:

ChiCTR1900027133 

最近更新日期:

Date of Last Refreshed on:

2019-11-01 21:51:39 

注册时间:

Date of Registration:

2019-11-01 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

Insulin resistance and vitamin D deficiency are frequently seen in diabetic patients. Vitamin D deficiency can have a negative effect on blood glucose level and weight loss.

Public title:

Insulin resistance and vitamin D deficiency are frequently seen in diabetic patients. Vitamin D deficiency can have a negative effect on blood glucose level and weight loss.

注册题目简写:

English Acronym:

研究课题的正式科学名称:

Determination of vitamin D levels of patients with diabetes and insulin resistance

Scientific title:

Determination of vitamin D levels of patients with diabetes and insulin resistance

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:

Gülin Oztürk Ozkan 

研究负责人:

Gülin Oztürk Ozkan 

Applicant:

Gülin Oztürk Ozkan 

Study leader:

Gülin Oztürk Ozkan 

申请注册联系人电话:

Applicant telephone:

905054755653

研究负责人电话:

Study leader's
telephone:

905054755653

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:

glnzturk@gmail.com

研究负责人电子邮件:

Study leader's E-mail:

glnzturk@gmail.com

申请单位网址(自愿提供):

Applicant website(voluntary supply):

Istanbul Medeniyet University

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:

Istanbul Medeniyet University Cevizli Kampüsü Atalar Mah. ehit Hakan Kurban Cad. No:44 Kartal/stanbul

研究负责人通讯地址:

Istanbul Medeniyet University Cevizli Kampüsü Atalar Mah. ehit Hakan Kurban Cad. No:44 Kartal/stanbul

Applicant address:

Istanbul Medeniyet University Cevizli Kampüsü Atalar Mah. ?ehit Hakan Kurban Cad. No:44 Kartal/stanbul

Study leader's address:

Istanbul Medeniyet Universitesi Cevizli Kampüsü Atalar Mah. ?ehit Hakan Kurban Cad. No:44

申请注册联系人邮政编码:

Applicant postcode:

34862

研究负责人邮政编码:

Study leader's postcode:

34862

申请人所在单位:

土耳其伊斯坦布尔医科大学

Applicant's institution:

Istanbul Medeniyet University

研究负责人所在单位:

土耳其伊斯坦布尔医科大学

Affiliation of the Leader:

Istanbul Medeniyet University

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

N/A

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:

Istanbul Medeniyet University

Name of the ethic committee:

Istanbul Medeniyet University

伦理委员会批准日期:

Date of approved by ethic committee:

2018-01-06 00:00:00

伦理委员会联系人:

Dr. Dyt

Contact Name of the ethic committee:

Dr. Dyt

伦理委员会联系地址:

Istanbul Medeniyet University Cevizli Kampüsü Atalar Mah. ehit Hakan Kurban Cad. No:44 Kartal/stanbul, Türkiye

Contact Address of the ethic committee:

Istanbul Medeniyet University Cevizli Kampüsü Atalar Mah. ehit Hakan Kurban Cad. No:44 Kartal/stanbul, Türkiye

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:

No sponsors

Primary sponsor:

No sponsors

研究实施负责(组长)单位地址:

No sponsors

Primary sponsor's address:

No sponsors

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

There is no funding for this research

Source(s) of funding:

There is no funding for this research

研究疾病:

Diabetes, insulin resistance  

Target disease:

Diabetes, insulin resistance

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

研究设计:

连续入组 

Study design:

Sequential 

研究目的:

This study was conducted to evaluate vitamin D levels in patients with type 2 diabetes, insulin resistance, obesity and impaired fasting glucose.  

Objectives of Study:

This study was conducted to evaluate vitamin D levels in patients with type 2 diabetes, insulin resistance, obesity and impaired fasting glucose.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

Pediatric patients, pregnant women, patients who do not have the diseases that are the subject of the research, patients who have the diseases that are not the subject of the research in addition to the diseases that are the subject of the research and who do not have the necessary biochemical measurements will not be included in the study.

Exclusion criteria:

Pediatric patients, pregnant women, patients who do not have the diseases that are the subject of the research, patients who have the diseases that are not the subject of the research in addition to the diseases that are the subject of the research and who do not have the necessary biochemical measurements will not be included in the study.

研究实施时间:

Study execute time:

From 2018-11-01 00:00:00 To 2019-06-28 00:00:00  

征募观察对象时间:

Recruiting time:

From 2018-11-01 00:00:00 To 2019-06-28 00:00:00

干预措施:

Interventions:

组别:

Case series

样本量:

500

Group:

Case series

Sample size:

干预措施:

No intervention

干预措施代码:

Intervention:

No intervention

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

土耳其

省(直辖市):

伊斯坦布尔 

市(区县):

Istanbul 

Country:

Türkiye

Province:

Istanbul

City:

Istanbul

单位(医院):

Haydarpasa Numune Education and Training Hospital 

单位级别:

Istanbul Medeniyet University 

Institution
hospital:

Haydarpasa Numune Education and Training Hospital

Level of the institution:

Istanbul Medeniyet University

测量指标:

Outcomes:

指标中文名:

Level of D vitamin

指标类型:

主要指标

Outcome:

Level of D vitamin

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:

Blood

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:

结束

/Completed

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

N/A

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

N/A, All of the patients who came to the diet policlinic within the time frame of the study and who met the research criteria were included in the study.

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:

N/A

Blinding:

N/A

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

否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):

Research protocol not published on the web

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

Research protocol not published on the web

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:

Standart data collection

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

Standart data collection

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2019-11-01 21:51:39