UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043480 |
|---|---|
| Receipt number | R000047250 |
| Scientific Title | Predicting the need for hypoglycemic treatment for elevated blood glucose levels, a side effect of corticosteroid treatments such as collagen disease |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2021/03/01 14:30:57 |
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Basic information
Public title
Predicting the need for hypoglycemic treatment for elevated blood glucose levels, a side effect of corticosteroid treatments such as collagen disease
Acronym
Predicting the need for hypoglycemic treatment for elevated blood glucose levels, a side effect of corticosteroid treatments such as collagen disease
Scientific Title
Predicting the need for hypoglycemic treatment for elevated blood glucose levels, a side effect of corticosteroid treatments such as collagen disease
Scientific Title:Acronym
Predicting the need for hypoglycemic treatment for elevated blood glucose levels, a side effect of corticosteroid treatments such as collagen disease
Region
| Japan |
Condition
Condition
Collagen disease
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Create a scoring system that predicts the need for hypoglycemic agents after administration of corticosteroids in patients who were admitted to the Department of Internal Medicine, Gifu University Hospital and treated with corticosteroids.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose level
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or older who were admitted to the Department of General Internal Medicine, Gifu University Hospital from June 1, 2004 to July 31, 2020, were diagnosed with collagen disease, and were given prednisolone 5 mg/day or more for 4 weeks or more
Key exclusion criteria
(1)patients who are already on hypoglycemic drugs at the start of prednisolone
(2)patients who are taking 15 mg/day or more of prednisolone before admission
(3)patients with anti-cancer chemotherapy
(4)patients who offered to be excluded from the study
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Ayaka |
| Middle name | |
| Last name | Kato |
Organization
Gifu University Hospital
Division name
Comprehensive pathology internal medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu City, Gifu Prefecture
TEL
058-230-6632
rinri@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Ayaka |
| Middle name | |
| Last name | Kato |
Organization
Gifu University Hospital
Division name
Comprehensive pathology internal medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu City, Gifu Prefecture
TEL
058-230-6632
Homepage URL
rinri@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University Hospital comprehensive pathology internal medicine
Institute
Department
Personal name
Funding Source
Organization
Gifu University Hospital comprehensive pathology internal medicine
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
Gifu University Hospital
Address
1-1 Yanagido, Gifu City, Gifu Prefecture
Tel
058-230-6632
rinri@gifu-u.ac.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
| 2021 | Year | 03 | 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
509
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
| 2004 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2021 | Year | 03 | Month | 01 | Day |
Last modified on
| 2021 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047250
