UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective observational study on prediction of impaired glucose tolerance after initiation of glucocorticoid therapy for non-diabetic patients
Title of the study (Brief title)	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	Yuko Okada
Organization	Kobe University Hospital
Division name	Division of Diabetes and Endocrinology
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	Tomoko Yamada
Organization	Kobe University Hospital
Division name	Division of Diabetes and Endocrinology
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 09 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000033405