UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043480
Receipt number R000047250
Scientific Title Predicting the need for hypoglycemic treatment for elevated blood glucose levels, a side effect of corticosteroid treatments such as collagen disease
Date of disclosure of the study information 2021/03/01
Last modified on 2021/03/01 14:30:57

* 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

Predicting the need for hypoglycemic treatment for elevated blood glucose levels, a side effect of corticosteroid treatments such as collagen disease

Acronym

Predicting the need for hypoglycemic treatment for elevated blood glucose levels, a side effect of corticosteroid treatments such as collagen disease

Scientific Title

Predicting the need for hypoglycemic treatment for elevated blood glucose levels, a side effect of corticosteroid treatments such as collagen disease

Scientific Title:Acronym

Predicting the need for hypoglycemic treatment for elevated blood glucose levels, a side effect of corticosteroid treatments such as collagen disease

Region

Japan


Condition

Condition

Collagen disease

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Create a scoring system that predicts the need for hypoglycemic agents after administration of corticosteroids in patients who were admitted to the Department of Internal Medicine, Gifu University Hospital and treated with corticosteroids.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Blood glucose level

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

100 years-old >

Gender

Male and Female

Key inclusion criteria

Patients aged 20 years or older who were admitted to the Department of General Internal Medicine, Gifu University Hospital from June 1, 2004 to July 31, 2020, were diagnosed with collagen disease, and were given prednisolone 5 mg/day or more for 4 weeks or more

Key exclusion criteria

(1)patients who are already on hypoglycemic drugs at the start of prednisolone
(2)patients who are taking 15 mg/day or more of prednisolone before admission
(3)patients with anti-cancer chemotherapy
(4)patients who offered to be excluded from the study

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Ayaka
Middle name
Last name Kato

Organization

Gifu University Hospital

Division name

Comprehensive pathology internal medicine

Zip code

501-1194

Address

1-1 Yanagido, Gifu City, Gifu Prefecture

TEL

058-230-6632

Email

rinri@gifu-u.ac.jp


Public contact

Name of contact person

1st name Ayaka
Middle name
Last name Kato

Organization

Gifu University Hospital

Division name

Comprehensive pathology internal medicine

Zip code

501-1194

Address

1-1 Yanagido, Gifu City, Gifu Prefecture

TEL

058-230-6632

Homepage URL


Email

rinri@gifu-u.ac.jp


Sponsor or person

Institute

Gifu University Hospital comprehensive pathology internal medicine

Institute

Department

Personal name



Funding Source

Organization

Gifu University Hospital comprehensive pathology internal medicine

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

Gifu University Hospital

Address

1-1 Yanagido, Gifu City, Gifu Prefecture

Tel

058-230-6632

Email

rinri@gifu-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

2021 Year 03 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

509

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

No longer recruiting

Date of protocol fixation

2004 Year 06 Month 01 Day

Date of IRB

2020 Year 09 Month 02 Day

Anticipated trial start date

2020 Year 09 Month 03 Day

Last follow-up date

2024 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

observational study


Management information

Registered date

2021 Year 03 Month 01 Day

Last modified on

2021 Year 03 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047250


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name