UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of epidural dexamethasone injection on glucose tolerance and the function of the adrenal glands
Title of the study (Brief title)	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	Shizuko Kosugi
Organization	Keio University School of Medicine
Division name	Department of Anesthesiology
Address	35 Shinanomachi, Shinjukuku, Tokyo
TEL	03-5363-3810
Email	shizuko.kosugi@gmail.com

Public contact
Name of contact person	Shizuko Kosugi
Organization	Keio University School of Medicine
Division name	Department of Anesthesiology
Address	35 Shinanomachi, Shinjukuku, Tokyo
TEL	03-5363-3810
Homepage URL
Email	shizuko.kosugi@gmail.com

Sponsor
Institute	Keio University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 08 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030618