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 |
* 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
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
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
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
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
