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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024971
Receipt No. 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

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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
Email 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
Email nishimura.haruki@qst.go.jp

Sponsor
Institute National Institutes for Quantum and Radiological Science and Technology
National Institute of Radiological Sciences
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028732

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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