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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000047747 |
Receipt No. | 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 |
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 |
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Condition | ||||
Condition | obesity, diabetes, insulin resistance, glucose intolerance, chronic kidney disease, hypertension, dyslipidemia | |||
Classification by specialty |
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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 | |
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Purpose of intervention | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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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 |