UMIN-CTR Clinical Trial

Basic information
Public title	Assessment of tissue elasticity and lipid content by using ultrasound and its clinical implication
Acronym	Assessment of tissue elasticity and its clinical implication
Scientific Title	Assessment of tissue elasticity and lipid content by using ultrasound and its clinical implication
Scientific Title:Acronym	Assessment of tissue elasticity and its clinical implication
Region	Japan

Condition
Condition	obesity, diabetes, insulin resistance, glucose intolerance, chronic kidney disease, hypertension, dyslipidemia
Classification by specialty	Medicine in general Endocrinology and Metabolism Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the relationship between tissue (subcutaneous adipose tissue, liver, kidney) elasticity and hepatic lipid content and clinical data
Basic objectives2	Others
Basic objectives -Others	Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The relationship between tissue (subcutaneous adipose tissue, liver, kidney) elasticity and hepatic lipid content and clinical data including; 1) Medical record (e.g. height, weight, blood pressure, age, sex) 2) Medical prognosis 3) Blood and urine tests (e.g. glucose, HbA1c, TC, LDL-C, HDL-C, TG, Cre, BUN, Alb, AST, ALT, gGTP, ALP, U-TP/Cre) 4) Physiological function test (e.g. electrocardiogram, echocardiography) 5) Imaging data (e.g. computed tomography (CT))
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	The outpatients (who are older than or equal to 20 years old) in the Division of Endocrinology Metabolism and Nephrology, Keio University Hospital who have given written informed consent to this study.
Key exclusion criteria	The outpatients who do not give written informed consent to this study.
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Jun Middle name Last name Yoshino
Organization	Keio University School of Medicine
Division name	Division of Endocrinology, Metabolism, and Nephrology
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku, Tokyo
TEL	03-3353-1211
Email	jyoshino@keio.jp

Public contact
Name of contact person	1st name Jun Middle name Last name Yoshino
Organization	Keio University School of Medicine
Division name	Division of Endocrinology, Metabolism, and Nephrology
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku, Tokyo
TEL	03-3353-1211
Homepage URL
Email	jyoshino@keio.jp

Sponsor
Institute	Keio University Keio University School of Medince Division of Endocrinology, Metabolism, and Nephrology
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Ethics Committee in Keio University School of Medicine
Address	35 Shinanomachi, Shinjuku, Tokyo
Tel	03-3353-1211
Email	https://www.ctr.med.keio.ac.jp/forms/

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	慶應義塾大学病院

Other administrative information
Date of disclosure of the study information	2022 Year 05 Month 15 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	Enrolling by invitation
Date of protocol fixation	2022 Year 02 Month 03 Day
Date of IRB	2022 Year 02 Month 03 Day
Anticipated trial start date	2022 Year 05 Month 16 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The purpose of this study is to evaluate the relationship between tissue (subcutaneous adipose tissue, liver, kidney) elasticity and lipid content and clinical data.

Management information
Registered date	2022 Year 05 Month 13 Day
Last modified on	2022 Year 05 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054420

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.