UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032013 |
|---|---|
| Receipt number | R000036467 |
| Scientific Title | Examination for factors affecting sleep apnea in patients of type 2 diabetes mellitus. |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2023/04/05 12:12:43 |
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Basic information
Public title
Examination for factors affecting sleep apnea in patients of type 2 diabetes mellitus.
Acronym
Examination for factors affecting sleep apnea.
Scientific Title
Examination for factors affecting sleep apnea in patients of type 2 diabetes mellitus.
Scientific Title:Acronym
Examination for factors affecting sleep apnea.
Region
| Japan |
Condition
Condition
Type 2 Diabetes Mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine relationsip Muscle Mass / Fat Mass by Body Composition Analysis and presence of OSAS in Japanese Type 2 DM.
Basic objectives2
Others
Basic objectives -Others
To examine relationsip blood tests and presence of OSAS in Japanese Type 2 DM.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
presence of OSAS
Key secondary outcomes
Muscle / Fat Mass by Body Composition Analysis
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
type 2 Diabetes Mellitus
Key exclusion criteria
No
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noboru Kurinami |
Organization
Jinnouchi Hospital
Division name
Diabetes Care Center
Zip code
Address
6-2-3, Kuhonji Chuo-ku, Kumamoto-City, Kumamoto Japan
TEL
096-363-0011
kurinami@jinnouchi.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noboru Kurinami |
Organization
Jinnouchi Hospital
Division name
Diabetes Care Center
Zip code
Address
6-2-3, Kuhonji Chuo-ku, Kumamoto-City, Kumamoto Japan
TEL
096-363-0011
Homepage URL
kurinami@jinnouchi.or.jp
Sponsor or person
Institute
Jinnouchi Hospital
Institute
Department
Personal name
Funding Source
Organization
Jinnouchi Hospital
Organization
Division
Category of Funding Organization
Self funding
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
陣内病院（熊本）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | 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
| 2018 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All patients with untreated T2DM who visited the Diabetes Care Center of Jinnouchi Hospital between June 2015 and October 2018
Management information
Registered date
| 2018 | Year | 03 | Month | 30 | Day |
Last modified on
| 2023 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036467
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
