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  • Status : Approved
    • First Submitted Date : 2013/05/14
    • Registered Date : 2013/05/31
    • Last Updated Date : 2015/05/28
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1. Background

Background Information
CRIS
Registration Number
KCT0000760 
Unique Protocol ID 2012-1 
Public/Brief Title The effect of diabetes and diabetic control status on clinical manifestations and treatment response in patients of pulmonary tuberculosis 
Scientific Title The effect of diabetic control status on clinical manifestations and treatment response in patients of pulmonary tuberculosis  
Acronym  
MFDS Regulated Study No
IND/IDE Protocol No
Registered
at Other Registry
No
Healthcare Benefit
Approval Status
 

2. Institutional Review Board/Ethics Committee

Institutional Review Board Information
Board Approval Status Submitted approval 
Board Approval Number C2012158(853) 
Approval Date 2012-09-14 
Institutional Review Board  
Name Chung-Ang University Institutional Review Board· 
Address  
Telephone  
Data Monitoring Committee  

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Jae Chol Choi 
Title associate professor 
Telephone  
Affiliation Chung-Ang Univerisity Hospital 
Address  
Contact Person for Public Queries
Name Jae Woo Jung 
Title assistant professor 
Telephone  
Affiliation Chung-Ang Univerisity Hospital 
Address  
Contact Person for Updating Information
Name Jae chol Choi 
Title associate professor 
Telephone  
Affiliation Chung-Ang Univerisity Hospital 
Address  

4. Status

Status Information
Study Site Multi-center (Number of center : 10)
Overall Recruitment Status Completed  
Date of First Enrollment 2012-10-15 , Actual
Target Number of Participant 1,384
Primary Completion Date 2014-09-25 , Actual
Study Completion Date 2015-03-25 , Actual
Recruitment Status by Participating Study Site 1
Name of Study Site Hallym University Medical Center-Kangdong 
Recruitment Status Completed  
Date of First Enrollment 2012-11-15 , Actual
Recruitment Status by Participating Study Site 2
Name of Study Site Kyung Hee University Hosipital at Gangdong 
Recruitment Status Completed  
Date of First Enrollment 2012-12-26 , Actual
Recruitment Status by Participating Study Site 3
Name of Study Site Dongguk University Bundang Oriental Hospital 
Recruitment Status Completed  
Date of First Enrollment 2012-12-26 , Actual
Recruitment Status by Participating Study Site 4
Name of Study Site VHS Medical Center 
Recruitment Status Completed  
Date of First Enrollment 2013-01-21 , Actual
Recruitment Status by Participating Study Site 5
Name of Study Site Seoul Metropolitan Seobuk Hospital  
Recruitment Status Completed  
Date of First Enrollment 2013-04-13 , Actual
Recruitment Status by Participating Study Site 6
Name of Study Site Seoul National University Hospital 
Recruitment Status Completed  
Date of First Enrollment 2013-01-16 , Actual
Recruitment Status by Participating Study Site 7
Name of Study Site Ewha Womans University Medical Center 
Recruitment Status Completed  
Date of First Enrollment 2012-11-14 , Actual
Recruitment Status by Participating Study Site 8
Name of Study Site Chung-Ang Univerisity Hospital 
Recruitment Status Completed  
Date of First Enrollment 2012-10-15 , Actual
Recruitment Status by Participating Study Site 9
Name of Study Site IS Hallym Hospital 
Recruitment Status Completed  
Date of First Enrollment 2012-10-23 , Actual
Recruitment Status by Participating Study Site 10
Name of Study Site Eulji University Medical Center 
Recruitment Status Completed  
Date of First Enrollment 2013-01-07 , Actual

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Korean National Tuberculosis Association Korean Institute of Tuberculosis 
Organization Type Government  
Project ID 2012-KIT-003 

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
Organization Name Chung-Ang Univerisity Hospital 
Organization Type Medical Institute  

7. Study Summary

Study Summary Information
Lay Summary The World Health Organization estimates that 170 million people worldwide currently have diabetes, a figure that will double by 2030. Diabetes mellitus (DM) is known to be associated with an increased risk of tuberculosis. However, the immune responses of uncontrolled diabetic patients are different from those of controlled diabetics. Several studies suggest that impaired host defense is a consequence of uncontrolled hyperglycemia. However, recent data describing the possible effects of DM control on TB presentation and outcome are scarce.Therefore, the aim of the present study was to determine whether control status of diabetes influences clinical and radiographic manifestations and treatment response in patients with TB.
We will include newly diagnosed pulmonary tuberculosis patients over 18 years old. We will define the controlled DM by HbA1C (<7.0). We will compare the clinical symptom, radiographic findings, initial smear result and 2 months culture result between controlled diabetic group and uncontrolled diabetic group.
 

8. Study Design

Study Design Information
Study Type Observational Study 
Observational Study Model Cohort 
Time Perspective Prospective    
Target Number of Participant 1,384
Cohort/Group Number
Cohort/
Group 1
Cohort/Group
Label
active pulmonary TB patients with uncontrolled DM  
Cohort/Group
Description
active pulmonary TB patients with uncontrolled DM. Controlled status will be check by HbA1C(>7.0) We will evaluate the initial symptom, chest x-ray findings, sputum smear and culture result, 1 and 2 month smear and culture result, and outcome of treatment 
Biospecimen
Collection & Archiving
Not collect nor Archive 
Biospecimen Description  
Cohort/
Group 2
Cohort/Group
Label
active pulmonary TB patients with controlled DM  
Cohort/Group
Description
active pulmonary TB patients with uncontrolled DM. Controlled status will be check by HbA1C(<7.0) We will evaluate the initial symptom, chest x-ray findings, sputum smear and culture result, 1 and 2 month smear and culture result, and outcome of treatment 
Biospecimen
Collection & Archiving
Not collect nor Archive 
Biospecimen Description  
Cohort/
Group 3
Cohort/Group
Label
active pulmonary TB patients without DM 
Cohort/Group
Description
acitve pulmonary TB patients without DM. We will evaluate the initial symptom, chest x-ray findings, sputum smear and culture result, 1 and 2 month smear and cuture result, and outcome of treatment 
Biospecimen
Collection & Archiving
Not collect nor Archive 
Biospecimen Description  

9. Subject Eligibility

Subject Eligibility Information
Study Population Description Newly diagnosed active pulmonary TB patients (Age&gt;18yrs old)  
Sampling Method Non-probability sampling  
Condition(s)/Problem(s) * Certain infectious and parasitic diseases
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 18 Year ~ 75 Year
Description Newly diagnosed active pulmonary TB patients who started the treatment <br />  
Exclusion Criteria HIV positive populations <br />Extra-pulmonary TB <br />Age under 18 years old or over 75years old  
Healthy Volunteers No

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome Efficacy 
Primary Outcome(s) 1 
Outcome 2months culture positive rate 
Timepoint two months of treatment 
Secondary Outcome(s) 1 
Outcome treatment success rate 
Timepoint end of treatment 
Secondary Outcome(s) 2 
Outcome initial clinical parameters (symptoms, smear result, cavity in chest x-ray) 
Timepoint first day of enrollment  

11. Study Results and Publication

Study Results and Publication Information
Result Registered

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information
Sharing Statement Not provided at time of Registration 
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