UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029165 |
|---|---|
| Receipt number | R000033346 |
| Scientific Title | Utility of nerve ultrasound in diabetic neuropathy |
| Date of disclosure of the study information | 2017/09/19 |
| Last modified on | 2019/01/07 18:15:07 |
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Basic information
Public title
Utility of nerve ultrasound in diabetic neuropathy
Acronym
Utility of nerve ultrasound in diabetic neuropathy
Scientific Title
Utility of nerve ultrasound in diabetic neuropathy
Scientific Title:Acronym
Utility of nerve ultrasound in diabetic neuropathy
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The degree of nerve cross-sectional area increase in the continuation of hyperglycemia will be compared between diabetic patients group and healthy contorol group.In the diabetic patients group,study the relationship between nerve cross-sectional area and symptoms, tendon reflex, autonomic nerves function, HbA1c, duration of disease, vibration, tactile examination, nerve conduction study.
It is aimed to evaluate the relationship between nerve ultrasound and hyperglycemia and establish it as a new examination method suitable for early detection and follow - up of diabetic neuropathy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Nerve cross-sectional area at each measurement point.
Median nerve in the wrist,forearm,elbow,upper arm.
Tibial nerve in the behind the medial malleolus, popliteal.
Sural nerve in the lower leg.
Compare butween diabetic patients group and healthy contorol group.
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
We will perform the nerve ultrasound examination.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Diabetic patients group
Patients who were hospitalized as diabetes education within the research period, who does not apply the exclusion criteria and obtained consent to the study.
Healthy control group
Staffs of Kochi Medical School who does not apply the exclusion criteria and obtained consent to the study,does not have impaired glucose tolerance.
Key exclusion criteria
Patients who have a history of peripheral neuropathy due to a cause other than diabetes, or suffering from those diseases.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuna Yoshinaga |
Organization
Kochi Medical School Hospital
Division name
Clinical Laboratory Department
Zip code
Address
185-1 Kohasu,Oko-cho,Nankoku-shi,Kochi 783-8505, JAPAN
TEL
088-880-2427
jm-yuna_0309@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuna Yoshinaga |
Organization
Kochi Medical School Hospital
Division name
Clinical Laboratory Department
Zip code
Address
185-1 Kohasu,Oko-cho,Nankoku-shi,Kochi 783-8505, JAPAN
TEL
088-880-2427
Homepage URL
jm-yuna_0309@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School
Institute
Department
Personal name
Funding Source
Organization
Kochi Medical School
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
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 | 09 | Month | 19 | 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
| 2017 | Year | 08 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 12 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 15 | Day |
Last modified on
| 2019 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033346
