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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029165
Receipt No. 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

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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
Email 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
Email jm-yuna_0309@kochi-u.ac.jp

Sponsor
Institute Kochi Medical School
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033346

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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