UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000047747
Receipt number R000054420
Scientific Title Assessment of tissue elasticity and lipid content by using ultrasound and its clinical implication
Date of disclosure of the study information 2022/05/15
Last modified on 2022/05/13 08:30:23

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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 or person

Institute

Keio University
Keio University School of Medince
Division of Endocrinology, Metabolism, and Nephrology

Institute

Department

Personal name



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

Value
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