UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Utility of nerve ultrasound in diabetic neuropathy
Title of the study (Brief title)	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	Yuna Yoshinaga
Organization	Kochi Medical School Hospital
Division name	Clinical Laboratory Department
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	Yuna Yoshinaga
Organization	Kochi Medical School Hospital
Division name	Clinical Laboratory Department
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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