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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027704
Receipt No. 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

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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
Email 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
Email oida@gifu-u.ac.jp

Sponsor
Institute Gifu University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031735

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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