UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Prospective Cohort Study of the Predictive factors about Development of Glucocorticoid-induced Diabetes Mellitus in Patients with Rheumatic Disease
Title of the study (Brief title)	PD-DIMER a prospective cohort study of the Predictive factors about Development of glucocorticoid-induced DIabetes MEllitus in patients with Rheumatic Disease
Region	Japan

Condition
Condition	Rheumatic Disease
Classification by specialty	Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate factors for development of glucocorticoid-induced Diabetes Mellitus in patients with Rheumatic Disease
Basic objectives2	Others
Basic objectives -Others	Predictive factors
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	To clarify predictors of the factors for development of glucocorticoid-induced Diabetes Mellitus in patients with Rheumatic Disease
Key secondary outcomes	Correlation between factors for development of glucocorticoid-induced Diabetes Mellitus in patients with Rheumatic Disease

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients with rheumatic diseases who undergo inpatient treatment 2) Patients must be able to agree the informed consent.
Key exclusion criteria	1) Patients who refuse to participate this study 2) Patients for whom the physicians do not think suitable for this study
Target sample size	300

Research contact person
Name of lead principal investigator	Ken-ei Sada
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Address	2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, 700-8558
TEL	086-235-7235
Email	sadakenn@okayama-u.ac.jp

Public contact
Name of contact person	Yosuke Asano
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Address	2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, 700-8558
TEL	086-235-7235
Homepage URL
Email	asano-oka@umin.ac.jp

Sponsor
Institute	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2020 Year 10 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 07 Month 16 Day
Anticipated trial start date	2017 Year 10 Month 01 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	Before entry

Management information
Registered date	2017 Year 09 Month 05 Day
Last modified on	2017 Year 09 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033112