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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029225
Receipt No. 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

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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
Email 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
Email yamada@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


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