UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037899 |
|---|---|
| Receipt number | R000043131 |
| Scientific Title | Retrospective search for the origin that tarnished the illness relating to glucose metabolism severely in 10 years |
| Date of disclosure of the study information | 2019/09/02 |
| Last modified on | 2019/09/02 18:55:52 |
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Basic information
Public title
Retrospective search for the origin that tarnished the illness relating to glucose metabolism severely
Acronym
RESORT-GLUME study
Scientific Title
Retrospective search for the origin that tarnished the illness relating to glucose metabolism severely in 10 years
Scientific Title:Acronym
RESORT-GLUME study
Region
| Japan |
Condition
Condition
Diabetes and its complications
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the progression of diabetes and its complications. We then investigate the origin related to those.
Basic objectives2
Others
Basic objectives -Others
We investigate the origin that tarnished illness related to diabetes and its complications.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
We investigate the origin that tarnished illness related to diabetes and its complications.
Key secondary outcomes
We investigate the other factor, namely food intake and medications, related to the primary 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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Medical information and data in patients who visited to have any care or consultation in the internal medicine on Osaka central hospital between Jan. 1th. 2009. and Dec. 31th. 2018.
Key exclusion criteria
Medical information and data in patients who have no illness related to glucose metabolism.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Miuchi |
Organization
Osaka Central Hospital
Division name
Division of Diabetes, Endocrinology and Metabolism, and Respiratory Medicine in the Department of Internal Medicine. / Department of Nutrition
Zip code
530-0001
Address
3-3-30 Umeda, KItaku, Osaka city, Osaka, Japan
TEL
06-4795-5554
m-miuchi@osaka-centralhp.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Miuchi |
Organization
Osaka Central Hospital
Division name
Division of Diabetes, Endocrinology and Metabolism, and Respiratory Medicine in the Department of In
Zip code
530-0001
Address
3-3-30 Umeda, KItaku, Osaka city, Osaka, Japan
TEL
06-5794-5554
Homepage URL
m-miuchi@osaka-centralhp.jp
Sponsor or person
Institute
Department of Internal Medicine on Osaka Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Internal Medicine on Osaka Central Hospital
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
Research ethics committee on Osaka Central Hospital
Address
3-3-30 Umeda, Kitaku, Osaka city, Osaka, Japan
Tel
06-4795-5554
m-miuchi@osaka-centralhp.jp
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
| 2019 | Year | 09 | Month | 02 | 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
5000
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
RESORT-GLUME study is the retrospective analysis study.
Management information
Registered date
| 2019 | Year | 09 | Month | 02 | Day |
Last modified on
| 2019 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043131
| 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 |
