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
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
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
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 | |
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| Registered date | File name |
