UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028207 |
|---|---|
| Receipt number | R000032208 |
| Scientific Title | Case control study to determine the predisposing factors to develop diabetic ketoacidosis complicated with Hamman syndrome. |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2019/01/21 17:34:49 |
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Basic information
Public title
Case control study to determine the predisposing factors to develop diabetic ketoacidosis complicated with Hamman syndrome.
Acronym
Case control study of DKA with Hamman syndrome.
Scientific Title
Case control study to determine the predisposing factors to develop diabetic ketoacidosis complicated with Hamman syndrome.
Scientific Title:Acronym
Case control study of DKA with Hamman syndrome.
Region
| Japan |
Condition
Condition
Diabetic ketoacidosis
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the clinical factors of diabetic ketoacidosis with Hamman syndrome.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Mediastinal emphysema
Key secondary outcomes
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
| 10 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All types of diabetes mellitus
Key exclusion criteria
No exclusion criteria
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Uru Nezu Osada |
Organization
Saiseikai Yokohama City Nanbu Hospital
Division name
Department of Diabetes and Endocrinology
Zip code
Address
Kanagawa, Yokohama, Konan-ku Konandai 3-2-10, Japan
TEL
045-832-1111
amadeus@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yulia Namiki |
Organization
Saiseikai Yokohama City Nanbu Hospital
Division name
Department of Diabetes and Endocrinology
Zip code
Address
Kanagawa, Yokohama, Konan-ku Konandai 3-2-10, Japan
TEL
045-832-1111
Homepage URL
ynamiki.dm.metab@gmail.com
Sponsor or person
Institute
Saiseikai Yokohama City Nanbu Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2017 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2017 | Year | 07 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 30 | Day |
Other
Other related information
We first construct clinical database of diabetic ketoacidosis associated with and without Hamman syndrome. Then we aimed to exploer their clinical characteristics and risk factors.
Management information
Registered date
| 2017 | Year | 07 | Month | 13 | Day |
Last modified on
| 2019 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032208
