UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044327 |
|---|---|
| Receipt number | R000050495 |
| Scientific Title | Verification of the usefulness of a scoring system that predicts the need for hypoglycemic therapy for elevated blood glucose levels, which is a side effect of corticosteroid treatment in collagen diseases, etc. |
| Date of disclosure of the study information | 2021/05/25 |
| Last modified on | 2021/05/25 20:05:53 |
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Basic information
Public title
Verification of the usefulness of a scoring system that predicts the need for hypoglycemic therapy for elevated blood glucose levels, which is a side effect of corticosteroid treatment in collagen diseases, etc.
Acronym
Verification of the usefulness of a scoring system that predicts the need for hypoglycemic therapy for elevated blood glucose levels, which is a side effect of corticosteroid treatment in collagen diseases, etc.
Scientific Title
Verification of the usefulness of a scoring system that predicts the need for hypoglycemic therapy for elevated blood glucose levels, which is a side effect of corticosteroid treatment in collagen diseases, etc.
Scientific Title:Acronym
Verification of the usefulness of a scoring system that predicts the need for hypoglycemic therapy for elevated blood glucose levels, which is a side effect of corticosteroid treatment in collagen diseases, etc.
Region
| Japan |
Condition
Condition
collagen diseases
Classification by specialty
| Medicine in general | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the usefulness of a scoring system
Basic objectives2
Others
Basic objectives -Others
Verification
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Age, fasting blood glucose, BMI, prednisolone 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
From April 1, 2012 to July 31, 2020, they are admitted to Gifu Municipal Hospital General Medical Care / Rheumatology Collagen Disease Center, Gifu Prefectural General Medical Center Internal Medicine / General Medical Care / Rheumatology Collagen Disease Department, and diagnosed with collagen disease Patients who received prednisolone 5 mg / day or more for 4 weeks or more.
Key exclusion criteria
Patients who are already taking hypoglycemic drugs at the start of prednisolone.
Patients who have been taking prednisolone of 15 mg / day or more before admission.
Patients who also received anti-cancer chemotherapy.
Patients who have offered to be excluded from research.
Target sample size
240
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
0582306000
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
0582306632
Homepage URL
rinri@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Gifu University 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
Gifu University Hospital
Address
1-1 Yanagido, Gifu City, Gifu Prefecture
Tel
0582306000
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 | 05 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 08 | 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 | 05 | Month | 25 | Day |
Last modified on
| 2021 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050495
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
