UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029225 |
|---|---|
| Receipt number | R000033405 |
| Scientific Title | Prospective observational study on prediction of impaired glucose tolerance after initiation of glucocorticoid therapy for non-diabetic patients |
| Date of disclosure of the study information | 2017/09/21 |
| Last modified on | 2018/03/23 09:48:10 |
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Basic information
Public title
Prospective observational study on prediction of impaired glucose tolerance after initiation of glucocorticoid therapy for non-diabetic patients
Acronym
Prospective observational study on prediction of impaired glucose tolerance after initiation of glucocorticoid therapy for non-diabetic patients
Scientific Title
Prospective observational study on prediction of impaired glucose tolerance after initiation of glucocorticoid therapy for non-diabetic patients
Scientific Title:Acronym
Prospective observational study on prediction of impaired glucose tolerance after initiation of glucocorticoid therapy for non-diabetic patients
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the relationship between glucose metabolism index on 75g OGTT before glucocorticoid therapy and glucocorticoid-induced hyperglycemia
Basic objectives2
Others
Basic objectives -Others
physiology of glucose metabolism
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence or absence of onset of glucocorticoid-induced hyperglycemia 28 days after glucocorticoid therapy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.without diabetes mellitus
2.20 years of age or older
3.start glucocorticoid therapy at a dose of 20 mg / day or more in terms of PSL for skin diseases or collagen diseases.
4.use glucocorticoid more than 28 days at the start
5.before the study, able to understand our explanation on the study and obtain the written informed consent based on their own free will
Key exclusion criteria
1. Case of diabetes type at 75 g OGTT before glucocorticoid therapy.
2. Patients with severe renal dysfunction (serum Cre value before treatment start is greater than 1.5 mg / dl).
3. Cases with severe liver dysfunction (having decompensated cirrhosis or AST / ALT before treatment start more than 3 times higher than normal upper limit).
4. Cases with moderate inflammatory findings (CRP > 1.0 mg / dl or body temperature > 38.0).
5. Patients with gastrointestinal surgery history.
6. Case of using a calcineurin inhibitor.
7. Cases with malignant tumors and being treated.
8. Pregnancy, brestfeeding cases.
9. Other cases that the researcher deemed inappropriate.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuko Okada |
Organization
Kobe University Hospital
Division name
Division of Diabetes and Endocrinology
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-5111
yokada@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko Yamada |
Organization
Kobe University Hospital
Division name
Division of Diabetes and Endocrinology
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-5111
Homepage URL
yamada@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
donation
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
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
| 2017 | Year | 09 | Month | 21 | 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
| 2017 | Year | 09 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design: Case-control study
Study Subjects: all non-diabetic individuals starting treatment of glucocorticoid with normal glucose tolerance or impaired glucose tolerance who meet the selection criteria and are recruited in Kobe University hospital from September 21, 2017 to December 31, 2020
Management information
Registered date
| 2017 | Year | 09 | Month | 21 | Day |
Last modified on
| 2018 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033405
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
