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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name