UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Confirmatory study of high resolution ultrasound imaging of the carotid artery using frequency domain interferometry
Title of the study (Brief title)	Confirmatory study of high resolution ultrasound imaging
Region	Japan

Condition
Condition	diabetes mellitus
Classification by specialty	Endocrinology and Metabolism Laboratory medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation of the performance of the high-resolution method for carotid artery imaging.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We investigate the performance of the high-resolution method in depicting arterial wall of human carotid artery.
Key secondary outcomes	We compare the carotid intima-media thickness and the blood test values. We investigate the performance of the ultrasound elastography imaging method for carotid artery.

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	Acquiring the ultrasound image of carotid artery.
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	1) Inpatients of Department of Diabetes and Clinical Nutrition, Kyoto University, with diabetes mellitus type 1 or 2. 2) The age of a patient ranges from 20 to 80 at the registration. 3) The patient gives a written consent to participate in this study.
Key exclusion criteria	1) Patient with a cardiac pacemaker. 2) Patient receiving total parenteral nutrition. 3) Patient with stents at both of the carotid arteries. 4) Patient with carotid endarterectomy at both of the carotid arteries. 5) Patient with walking difficulty. 6) Pregnant woman, woman who has a possibility to be pregnant, and woman at lactation period. 7) Patient who is inappropriate to this study, judged by the lead principal investigator or the doctor in attendance.
Target sample size	30

Research contact person
Name of lead principal investigator	Tsuyoshi Shiina
Organization	Kyoto University
Division name	Graduate School of Medicine
Address	53, Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
TEL	075-751-4998
Email	shiina.tsuyoshi.6w@kyoto-u.ac.jp

Public contact
Name of contact person	Toru Sato
Organization	Kyoto University
Division name	Graduate School of Informatics
Address	Yoshida-honmachi, Sakyo-ku, Kyoto 606-8501, Japan
TEL	075-753-3365
Homepage URL
Email	sato.toru.6e@kyoto-u.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

Funding Source
Organization	Innovative Techno-Hub for Integrated Medical Bio-imaging Project of the Special Coordination Funds for Promoting Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Tohoku University
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	京都大学医学部附属病院（京都府）

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 19 Day
Anticipated trial start date	2015 Year 07 Month 01 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete	2016 Year 03 Month 31 Day
Date analysis concluded	2016 Year 03 Month 31 Day

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

Management information
Registered date	2015 Year 06 Month 26 Day
Last modified on	2018 Year 09 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020948