UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prediction of requirement of hypoglycemic therapies for hyperglycemia induced by steroidal treatment for collagen vascular disease, etc.
Title of the study (Brief title)	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	Hiroyuki Morita
Organization	Gifu University Hospital
Division name	Department of General Internal Medicine
Address	1-1 Yanagido, Gifu
TEL	058-230-6632
Email	hmorita@gifu-u.ac.jp

Public contact
Name of contact person	Mikako Kawashima
Organization	Gifu University Hospital
Division name	Department of General Internal Medicine
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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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