UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027704 |
|---|---|
| Receipt number | R000031735 |
| Scientific Title | Prediction of requirement of hypoglycemic therapies for hyperglycemia induced by steroidal treatment for collagen vascular disease, etc. |
| Date of disclosure of the study information | 2017/06/09 |
| Last modified on | 2017/06/09 13:35:10 |
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Basic information
Public title
Prediction of requirement of hypoglycemic therapies for hyperglycemia induced by steroidal treatment for collagen vascular disease, etc.
Acronym
Developing and validation of the scoring system for prediction of requirement of hypoglycemic therapies including insulin for hyperglycemia during glucocorticoid treatment (Multicenter Retrospective Study)
Scientific Title
Prediction of requirement of hypoglycemic therapies for hyperglycemia induced by steroidal treatment for collagen vascular disease, etc.
Scientific Title:Acronym
Developing and validation of the scoring system for prediction of requirement of hypoglycemic therapies including insulin for hyperglycemia during glucocorticoid treatment (Multicenter Retrospective Study)
Region
| Japan |
Condition
Condition
Glucocorticoid-induced diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Developing and validation of the scoring system for prediction of insulin requirement for hyperglycemia during glucocorticoid treatment.
Basic objectives2
Others
Basic objectives -Others
Compare the following clinical parameters; sex,age,fever,weight,height,body mass index,underlying diseases,laboratory data (total protein,albumin,aspartate aminotransferase,alanine aminotransferase,lactate dehydrogenase,alkaline phosphatase,gamma glutamyl transpeptidase,creatinine,uric acid,urea nitrogen,C reactive protein, HbA1c,fasting plasma glucose White blood cell count,white blood cell differentiation,red blood cell count,hemoglobin,platelet count),and initial dose of glucocorticoid (in terms of PSL mg/day),and pulse therapy between insulin and non-insulin groups in the Developing set.Subsequently,develop scoring system according to statistical analyses of these parameters in the Developing set.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Administration of insulin therapy during
glucocorticoid treatment
Key secondary outcomes
Administration of oral hypoglycemic agentsand glucagon like peptide 1 receptor agonist
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Developing set
patients admitted in Department of General Internal Medicine, Gifu University Hospital between 1 June 2004 and 31 July 2016.
Validation set
A: admitted in Department of General Internal Medicine, Gifu Prefectural General Medical Center between 1 April 2012 and 31 July 2016.
B: admitted in Center of General Internal Medicine and Rheumatology, Gifu Municipal Hospital between 1 April 2012 and 31 July 2016.
Inclusion criteria applied to the Developing set, and Validation set A and B indicate that patients were 20 years of age or older and the glucocorticoid treatment with the dosage of prednisolone more than 5 mg/day for 4 weeks at least was administered for the first time.
Key exclusion criteria
Exclusion criterion indicates taking concomitantly anti-cancer drugs
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Morita |
Organization
Gifu University Hospital
Division name
Department of General Internal Medicine
Zip code
Address
1-1 Yanagido, Gifu
TEL
058-230-6632
hmorita@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mikako Kawashima |
Organization
Gifu University Hospital
Division name
Department of General Internal Medicine
Zip code
Address
1-1 Yanagido, Gifu
TEL
058-230-6632
Homepage URL
oida@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University Graduate School of Medicine
Institute
Department
Personal name
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)
None
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
岐阜大学医学部附属病院総合内科（岐阜県）
岐阜県総合医療センター内科・総合診療科（岐阜県）
岐阜市民病院総合内科・膠原病内科（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 09 | 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 | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Develop the scoring system for prediction of insulin requirement during glucocorticoid treatment by retrospective observational study based on the medical record information of inpatients who received glucocorticoid therapy in Department of General Internal Medicine, Gifu University Hospital between 1 June 2004 and 31 July 2016 (Developing set).
Subsequently,
evaluate clinical utility and varidity of the scoring system, according to retrospective analyses of medical record information of inpatients who received glucocorticoid therapy in Department of General Internal Medicine, Gifu Prefectural General Medical Center between 1 April 2012 and 31 July 2016, and Center of General Internal Medicine and Rheumatology, Gifu Municipal Hospital between 1 April 2012 and 31 July 2016, respectively.(Validation set A and B)
Management information
Registered date
| 2017 | Year | 06 | Month | 09 | Day |
Last modified on
| 2017 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031735
