UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026675
Receipt number R000030618
Scientific Title Effects of epidural dexamethasone injection on glucose tolerance and the function of the adrenal glands
Date of disclosure of the study information 2017/03/23
Last modified on 2017/09/22 14:10:32

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Basic information

Public title

Effects of epidural dexamethasone injection on glucose tolerance and the function of the adrenal glands

Acronym

Effects of epidural dexamethasone on glucose tolerance and adrenal function

Scientific Title

Effects of epidural dexamethasone injection on glucose tolerance and the function of the adrenal glands

Scientific Title:Acronym

Effects of epidural dexamethasone on glucose tolerance and adrenal function

Region

Japan


Condition

Condition

Low back pain

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the effects of multiple epidural dexamethasone injections on glucose tolerance and the function of adrenal glands between diabetic patients and non-diabetic patients.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The change in HbA1c levels:HbA1c at 2 months after the initial treatment minus HbA1c at baseline

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

50 years-old <=

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

Patients with low back pain due to lumber spinal disease and aged over 50.

Diabetes group: history of diabetes mellitus or the results of blood sample at baseline show either fasting blood glucose>126mg/dl, casual blood glucose>200mg/dl or HbA1c>6.5

Non-diabetes group: Other than that above

Key exclusion criteria

Steroid use within past 6 months, patients with allergy to contrast dye, local anesthetic, and dexamethasone, ones with coagulopathy, the pregnant, severe diabetes, obesity (BMI>30kg/m2 ), severe dyslipidemia

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shizuko Kosugi

Organization

Keio University School of Medicine

Division name

Department of Anesthesiology

Zip code


Address

35 Shinanomachi, Shinjukuku, Tokyo

TEL

03-5363-3810

Email

shizuko.kosugi@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Shizuko Kosugi

Organization

Keio University School of Medicine

Division name

Department of Anesthesiology

Zip code


Address

35 Shinanomachi, Shinjukuku, Tokyo

TEL

03-5363-3810

Homepage URL


Email

shizuko.kosugi@gmail.com


Sponsor or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Departmental source

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


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 03 Month 23 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

2015 Year 08 Month 04 Day

Date of IRB


Anticipated trial start date

2015 Year 11 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2017 Year 03 Month 23 Day

Last modified on

2017 Year 09 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030618


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name