UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018249 |
|---|---|
| Receipt number | R000021087 |
| Scientific Title | Latent tuberculosis infection (LTBI) and risk of geting sick in patients with poorly controlled diabetes mellitus |
| Date of disclosure of the study information | 2015/07/08 |
| Last modified on | 2016/11/28 14:24:05 |
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Basic information
Public title
Latent tuberculosis infection (LTBI) and risk of geting sick in patients with poorly controlled diabetes mellitus
Acronym
Latent tuberculosis infection in patients with diabetes mellitus
Scientific Title
Latent tuberculosis infection (LTBI) and risk of geting sick in patients with poorly controlled diabetes mellitus
Scientific Title:Acronym
Latent tuberculosis infection in patients with diabetes mellitus
Region
| Japan |
Condition
Condition
Poorly controlled diabetes mellitus
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A survey of the latent tuberculosis infection in patients with poorly controlled diabetes mellitus
Basic objectives2
Others
Basic objectives -Others
observation study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The percentage of the patients with latent tuberculosis infection in those with poorly controlled diabetes mellitus.
Key secondary outcomes
The percentage of the patients for whom latent tuberculosis infection is recommeded to be treated in those with poorly controlled diabetes mellitus.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients with diabetes mellitus whose HbAic is 7.0 or over 7.0
Key exclusion criteria
The patients who did not agree to participate in this research.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tamotsu Ishizuka |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Third Department of Internal Medicine
Zip code
Address
23-3 Matsuoka-Shimoaizuki, Eiheiji-cho, Yoshida-gun. Fukui 910-1193
TEL
0776-61-8355
tamotsui@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tamotsu Ishizuka |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Third Department of Internal Medicine
Zip code
Address
23-3 Matsuoka-Shimoaizuki, Eiheiji-cho, Yoshida-gun. Fukui 910-1193
TEL
0776-61-8355
Homepage URL
tamotsui@u-fukui.ac.jp
Sponsor or person
Institute
Third Department of Internal Medicine, Faculty of Medical Sciences, University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Third Department of Internal Medicine, Faculty of Medical Sciences, University of Fukui
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2016 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 11 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Investigation into the actual conditions and risk factors for tuberculosis in patinets with poorly controlled diabetes mellitus
Management information
Registered date
| 2015 | Year | 07 | Month | 08 | Day |
Last modified on
| 2016 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021087
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
