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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037040
Receipt No. R000042204
Scientific Title A clinical approach to reveal mechanism and treatment of glucocorticoid induced diabetes
Date of disclosure of the study information 2019/07/01
Last modified on 2020/09/11

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Basic information
Public title A clinical approach to reveal mechanism and treatment of steroid induced diabetes
Acronym A clinical approach to reveal mechanism and treatment of steroid induced diabetes
Scientific Title A clinical approach to reveal mechanism and treatment of glucocorticoid induced diabetes
Scientific Title:Acronym A clinical approach to reveal mechanism and treatment of glucocorticoid induced diabetes
Region
Japan

Condition
Condition Diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Understanding mechanism and treatment of glucocorticoids induced diabetes.
Basic objectives2 Others
Basic objectives -Others Considering while GLP-1 preparation is effective for the deterioration of glucose tolerance by steroid administration.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes measurement of HbA1c, glucose, IRI, glucagon, GLP-1, HOMA-R before and 3~6 months after the treatment of glucocorticoids.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Treatment with GLP-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
90 years-old >
Gender Male and Female
Key inclusion criteria Patients diagnosed as needing 5 mg/dL - 15 mg/dL predonisolone treatment.
Key exclusion criteria Patients who are allergic to the target drug
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Eiichi
Middle name
Last name Araki
Organization Kumamoto University Hospital
Division name Metabolic Medicine
Zip code 860-8556
Address 1-1-1 Honjo Chuoku Kumamoto city Kumamoto prefecture
TEL 096-373-5169
Email earaki@gpo.kumamoto-u.ac.jp

Public contact
Name of contact person
1st name Rieko
Middle name
Last name Goto
Organization Kumamoto University Hospital
Division name Metabolic Medicine
Zip code 860-8556
Address 1-1-1 Honjo Chuoku Kumamoto city Kumamoto prefecture
TEL 096-373-5169
Homepage URL
Email boots0gt@gmail.com

Sponsor
Institute Kumamoto University Hospital
Institute
Department

Funding Source
Organization Kumamoto University Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kumamoto University Hospital
Address 1-1-1 Honjo Chuoku Kumamoto city Kumamoto prefecture
Tel 096-344-2111
Email byi-senshin@jimu.kumamoto-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
2019 Year 07 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
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 Enrolling by invitation
Date of protocol fixation
2019 Year 07 Month 01 Day
Date of IRB
2019 Year 11 Month 29 Day
Anticipated trial start date
2019 Year 08 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 06 Month 12 Day
Last modified on
2020 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042204

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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