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Relationship between Estimated Average Glucose (eAG) and Fasting Plasma Glucose- in a Cohort of Pakistani Diabetic Subjects
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注册号：

Registration number：

 ChiCTR2100051577 

最近更新日期：

Date of Last Refreshed on：

 2021-09-27 

注册时间：

Date of Registration：

2021-09-27 

注册号状态：

补注册  

Registration Status：

Retrospective registration  

注册题目：

Relationship between Estimated Average Glucose (eAG) and Fasting Plasma Glucose- in a Cohort of Pakistani Diabetic Subjects 

Public title：

Relationship between Estimated Average Glucose (eAG) and Fasting Plasma Glucose- in a Cohort of Pakistani Diabetic Subjects 

注册题目简写：

 

English Acronym：

 

研究课题的正式科学名称：

Relationship between Estimated Average Glucose (eAG) and Fasting Plasma Glucose- in a Cohort of Pakistani Diabetic Subjects 

Scientific title：

Relationship between Estimated Average Glucose (eAG) and Fasting Plasma Glucose- in a Cohort of Pakistani Diabetic Subjects 

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：

Sibtain Ahmed 

研究负责人：

Sibtain Ahmed 

Applicant：

Sibtain Ahmed 

Study leader：

Sibtain Ahmed 

申请注册联系人电话：

Applicant telephone：

+922134861951 

研究负责人电话：

Study leader's telephone：

+922134861951 

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：

sibtain.ahmed@aku.edu 

研究负责人电子邮件：

Study leader's E-mail：

sibtain.ahmed@aku.edu 

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

AKU 

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：

Faculty office, Sopari wala building, Aga Khan University Hospital, Stadium Road, Karachi 

研究负责人通讯地址：

Faculty office, Sopari wala building, Aga Khan University Hospital, Stadium Road, Karachi 

Applicant address：

Faculty office, Sopari wala building, Aga Khan University Hospital, Stadium Road, Karachi 

Study leader's address：

Faculty office, Second floor, Sopari wala building, Aga Khan University Hospital, Stadium Road, Karachi 

申请注册联系人邮政编码：

Applicant postcode：

74800 

研究负责人邮政编码：

Study leader's postcode：

74800 

申请人所在单位：

巴基斯坦卡拉奇Aga Khan University 

Applicant's institution：

Aga Khan University 

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：

2020-5449-14410. 

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：

Aga Khan University Ethics Review Committee 

Name of the ethic committee：

Aga Khan University Ethics Review Committee 

伦理委员会批准日期：

Date of approved by ethic committee：

2020-10-09 

伦理委员会联系人：

Aga Khan University Ethics Review Committee, Karachi, Pakistan 

Contact Name of the ethic committee：

Aga Khan University Ethics Review Committee, Karachi, Pakistan 

伦理委员会联系地址：

Aga Khan University Ethics Review Committee, Karachi, Pakistan 

Contact Address of the ethic committee：

Aga Khan University Ethics Review Committee, Karachi, Pakistan 

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：

None 

Primary sponsor：

None 

研究实施负责（组长）单位地址：

None 

Primary sponsor's address：

None 

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

None 

Source(s) of funding：

None 

研究疾病：

Diabetes 

Target disease：

Diabetes 

研究疾病代码：

 

Target disease code：

 

研究类型：

诊断试验 

Study type：

Diagnostic test 

研究所处阶段：

回顾性研究 

Study phase：

Retrospective study 

研究目的：

Scientific literature is scarce on the utility of estimated average glucose (eAG) from Pakistan. Hence there is a dire need to evaluate the relationship between eAG and fasting plasma glucose (FPG), in order to enhance our understanding of eAG and its usefulness. This study aims to investigate the relationship between FPG and eAG in diabetic patients calculated using HbA1C. 

Objectives of Study：

Scientific literature is scarce on the utility of estimated average glucose (eAG) from Pakistan. Hence there is a dire need to evaluate the relationship between eAG and fasting plasma glucose (FPG), in order to enhance our understanding of eAG and its usefulness. This study aims to investigate the relationship between FPG and eAG in diabetic patients calculated using HbA1C. 

药物成份或治疗方案详述：

A retrospective study will be conducted by reviewing the medical records of both genders in age range of 18-60 years, presenting as outpatients at the endocrine clinic, consisting of diagnosed cases with diabetes, by a team consisting of a consultant chemical pathologist and endocrinologist, after exemption by the ERC. The biochemical investigations and demographic details will be collected on a pre-structured questionnaire. The identification details of the cases, including the medical record number will be visible only to the PI. In order to ensure security and confidentiality specific study IDs will be assigned by the PI for use by the project team.  

Description for medicine or protocol of treatment in detail：

A retrospective study will be conducted by reviewing the medical records of both genders in age range of 18-60 years, presenting as outpatients at the endocrine clinic, consisting of diagnosed cases with diabetes, by a team consisting of a consultant chemical pathologist and endocrinologist, after exemption by the ERC. The biochemical investigations and demographic details will be collected on a pre-structured questionnaire. The identification details of the cases, including the medical record number will be visible only to the PI. In order to ensure security and confidentiality specific study IDs will be assigned by the PI for use by the project team.  

研究设计：

连续入组 

Study design：

Sequential 

纳入标准：

Previously diagnosed diabetic patients who visited the endocrinology department for treatment follow up from 2013 to 2019, will be recruited for this study.  

Inclusion criteria

Previously diagnosed diabetic patients who visited the endocrinology department for treatment follow up from 2013 to 2019, will be recruited for this study.  

排除标准：

Exclusion Criteria: Patients with an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73 m2 will be excluded from the study as compromised renal function is known to interfere with HbA1C analysis.  

Exclusion criteria：

Exclusion Criteria: Patients with an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73 m2 will be excluded from the study as compromised renal function is known to interfere with HbA1C analysis.  

研究实施时间：

Study execute time：

从From2013-01-01至To 2019-12-31 

征募观察对象时间：

Recruiting time：

从From2013-04-01至To 2019-12-31 

诊断措施：

Diagnostic measures：

金标准或参考标准（即可准确诊断某疾病的单项方法或多项联合方法，在本研究中用于诊断是否有该病的临床参考标准）：

Fasting Plasma Glucose

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

Fasting Plasma Glucose

指标试验（即本研究的待评估诊断试验，无论为方法、生物标志物或设备，均请列出名称）：

Fasting Plasma Glucose

Index test:

estimated average glucose from HbA1c

目标人群（可以是某种疾病患者或正常人群，详细描述其疾病特征，注意应纳入符合分布特点的全序列病例，具有良好的代表性）

diabetes

例数:

Sample size:

4673

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

diabetes

容易混淆的疾病人群（即与目标疾病不易区分的一种或多种不同疾病，应避免采用正常人群对照的病例-对照设计）：

例数:

Sample size:

0

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

研究实施地点：

Countries of recruitment and research settings：

国家：

 巴基斯坦 

省(直辖市)：

 信德 

市(区县)：

 卡拉奇 

Country：

 Pakistan 

Province：

 Sindh 

City：

 Karachi 

单位(医院)：

 AKU 

单位级别：

 三级医院 

Institution
hospital：

 AKU  

Level of the institution：

 Tertiary care 

测量指标：

Outcomes：

指标中文名：

estimated average glucose

指标类型：

主要指标 

Outcome：

estimated average glucose

Type：

Primary indicator 

测量时间点：

clinic visit

测量方法：

calculation from HbA1c levels

Measure time point of outcome：

clinic visit

Measure method：

calculation from HbA1c levels

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织：

Sample Name：

None

Tissue：

None

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 18 岁 years
最大 Max age 60 岁 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）：

all diagnosed cases as per the inclusion exclusion criteria were included

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

all diagnosed cases as per the inclusion exclusion criteria were included

盲法：

The identification details of the cases, including the medical record number will be visible only to the PI. In order to ensure security and confidentiality specific study IDs will be assigned by the PI for use by the project team.

Blinding：

The identification details of the cases, including the medical record number will be visible only to the PI. In order to ensure security and confidentiality specific study IDs will be assigned by the PI for use by the project team.

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）：

Not stated

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

None

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：

Electronic data capture, password protected

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

Electronic data capture, password protected

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

 2021-09-27
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