UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Ultrasound diagnosis of carotid arterial atherosclerosis using phased tracking method
Title of the study (Brief title)	Diagnosis of atherosclerosis using phase tracking method of untrasound
Region	Japan

Condition
Condition	Diabetes Mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether the elasticiy of carotid artery measured using ultrasound phased tracking method associated with risk factors of atherosclerosis.
Basic objectives2	Others
Basic objectives -Others	To evaluate the association between the extent of atherosclerosis and risk factors.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cross sectional study. The association of the elasticiy of carotid artery measured using ultrasound phased tracking method and atherosclerotic risk factors (age, gender, blood pressure, glucose, lipid, kidney function, etc.).
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Patients having medical care at Department of Metabolism and Diabetes, Tohoku University Hospital.
Key exclusion criteria	Patients whose doctor do not agree to participate the study.
Target sample size	500

Research contact person
Name of lead principal investigator	Hideki Katagiri
Organization	Tohoku University Hospital
Division name	Department of Metabolism and Diabetes
Address	2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
TEL	022-717-7611
Email	katagiri@med.tohoku.ac.jp

Public contact
Name of contact person	Shojiro Sawada
Organization	Tohoku University Hospital
Division name	Department of Metabolism and Diabetes
Address	2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
TEL	022-717-7611
Homepage URL
Email	ssawada@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Hospital
Institute
Department

Funding Source
Organization	Tohoku University Hospital
Organization
Division
Category of Funding Organization	Self funding
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 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 11 Month 01 Day
Anticipated trial start date	2011 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Observational study To investigate the association between carotid arterial elasticity and risk factors of atherosclerosis, such as age, gender, blood pressure, glucose, lipids and kidney functions, we will analyse the cross sectional study.

Management information
Registered date	2017 Year 03 Month 31 Day
Last modified on	2017 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030750