UMIN-CTR Clinical Trial

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
Email	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
Email	rinri@gifu-u.ac.jp

Sponsor
Institute	Gifu University Hospital comprehensive pathology internal medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047250