UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029006 |
|---|---|
| Receipt number | R000033112 |
| Scientific Title | A Prospective Cohort Study of the Predictive factors about Development of Glucocorticoid-induced Diabetes Mellitus in Patients with Rheumatic Disease |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2017/09/05 16:03:12 |
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Basic information
Public title
A Prospective Cohort Study of the Predictive factors about Development of Glucocorticoid-induced Diabetes Mellitus in Patients with Rheumatic Disease
Acronym
PD-DIMER
a prospective cohort study of the Predictive factors about Development of glucocorticoid-induced DIabetes MEllitus in patients with Rheumatic Disease
Scientific Title
A Prospective Cohort Study of the Predictive factors about Development of Glucocorticoid-induced Diabetes Mellitus in Patients with Rheumatic Disease
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Ken-ei Sada |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, 700-8558
TEL
086-235-7235
sadakenn@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yosuke Asano |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, 700-8558
TEL
086-235-7235
Homepage URL
asano-oka@umin.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Preinitiation
Date of protocol fixation
| 2017 | Year | 07 | Month | 16 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033112
