UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024971 |
|---|---|
| Receipt number | R000028732 |
| Scientific Title | The investigation of pain experience with diabetic neuropathy |
| Date of disclosure of the study information | 2016/11/24 |
| Last modified on | 2019/06/03 20:08:45 |
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Basic information
Public title
The investigation of pain experience with diabetic neuropathy
Acronym
The investigation of pain experience with diabetic neuropathy
Scientific Title
The investigation of pain experience with diabetic neuropathy
Scientific Title:Acronym
The investigation of pain experience with diabetic neuropathy
Region
| Japan |
Condition
Condition
Painful diabetic neuropathy
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate relationships between painful diabetic neuropathy and brain images, cognitive function, physiological/psychological index
Basic objectives2
Others
Basic objectives -Others
To investigate relationships between painful diabetic neuropathy and brain images, cognitive function, physiological/psychological index
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The relationships between painful diabetic neuropathy and brain images, cognitive function, physiological/psychological index
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
MRI scan: 120min (including preparation and explanation)
Psychological test:
･Healthy individuals; 240min (including preparation and explanation and break time)
･Diabetic neuropathy; 180min (including preparation and explanation and break time)
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Diabetic neuropathy
･Patients who were diagnosed type 2 diabetes mellitus
･Patients complaining of neuropathic pain in the bilateral feet ( not includes only symptom of arms, coldness).
･Patients excluded other diagnoses which cause neuropathic pain.
･Patients with more than one month duration of symptom.
･Patients who understand written informed consent.
Healthy individuals
･Persons with no history of mental diseases.
･Persons with no history of diabete mellitus and other serious physical diseases.
･Persons who understand written informed consent.
Key exclusion criteria
Diabetic neuropathy
･Patients who showed a significant glycemic improvement by the treatment within four weeks from registration.
･Patients who are likely to experience significant glycemic improvement during the test period.
･Patients who are likely to require hospitalizations due to poor glycemic control.
･Patients with the involvement of alcoholic neuropathy.
･Patients with history of drug abuse or addiction.
･Patients with severe complications (cardiac failure, renal failure, hepatic failure, hemorrhagic peptic ulcers,bowel obstruction, malignant tumor, glaucoma.)
･Patients with pregnancy or desire to bear children.
･Patients who have metalic implants(cardiac pacemaker, intracephalic aneurysm clip, bolts, tattoo, etc).
･Patients with strong claustrophobia
･Patients with history of treatment to depression, bipolar disorder, anxiety disorder, anorexia nervosa within one year prior to the registration.
･Patients with totally blind.
･Patients considered inappropriate by investigators
Healthy individuals
･Persons with pregnancy or desire to bear children.
･Persons who have metalic implants(cardiac pacemaker, intracephalic aneurysm clip, bolts, tattoo, etc).
･Persons with strong claustrophobia
･Patients considered inappropriate by investigators
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Makiko |
| Middle name | |
| Last name | Yamada |
Organization
National Institutes for Quantum and Radiological Science and Technology
National Institute of Radiological Sciences
Division name
Department of Functional Brain Imaging Research
Zip code
263-8555
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
043-206-3251
yamada.makiko@qst.go.jp
Public contact
Name of contact person
| 1st name | Haruki |
| Middle name | |
| Last name | Nishimura |
Organization
National Institute of Radiological Sciences
Division name
Department of Functional Brain Imaging Research
Zip code
263-8555
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
043-206-3251
Homepage URL
nishimura.haruki@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum and Radiological Science and Technology
National Institute of Radiological Sciences
Institute
Department
Personal name
Funding Source
Organization
National Institutes for Quantum and Radiological Science and Technology
National Institute of Radiological Sciences
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
National Institute of Radiological Sciences
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
Tel
043-206-3025
helsinki@qst.go.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
千葉県
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 24 | 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
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2019 | 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
| 2016 | Year | 11 | Month | 24 | Day |
Last modified on
| 2019 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028732
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| Registered date | File name |
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