UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037040 |
|---|---|
| Receipt number | 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 | 2022/05/11 15:33:51 |
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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
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
boots0gt@gmail.com
Sponsor or person
Institute
Kumamoto University Hospital
Institute
Department
Personal name
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
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
Terminated
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
| 2022 | 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
| 2022 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042204
