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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028207
Receipt No. 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

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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
Email 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
Email ynamiki.dm.metab@gmail.com

Sponsor
Institute Saiseikai Yokohama City Nanbu Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032208

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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