UMIN-CTR Clinical Trial

Basic information
Public title	development of new measurement methods of liver fat volume by magnetic resonance imaging
Acronym	development of new measurement methods of liver fat volume by magnetic resonance imaging
Scientific Title	development of new measurement methods of liver fat volume by magnetic resonance imaging
Scientific Title:Acronym	development of new measurement methods of liver fat volume by magnetic resonance imaging
Region	Japan

Condition
Condition	Diabetes,Non-alcoholic fatty liver disease
Classification by specialty	Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	NAFLD(Non-alcoholic fatty liver disease) causes hepatic insulin resistance and diabetes. It is known that NASH(Non-alcoholic steatohepatitis) develops into liver cirrhosis and hepatic cell carcinoma. Diagnosis of NAFLD is based on intrahepatic lipid >=5% clinically, however, methods for hepatic lipid volume measurement remain to be improved regarding accuracy, and so on. So,we planned this research to develop MRI-based new method of hepatic lipid volume measurement. Results of this research may establish the more accurate measurement of hepatic lipid volume.
Basic objectives2	Others
Basic objectives -Others	validation of measurememt methods
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Liver volume,liver fat volume,whole hepatic lipid ratio,and lean hapatic volume are measured by newly developed MR imaging method.The association between these MR imaging data and all evaluated indices will be analyzed.Furthermore, ROC analysis,Pearson and Spearman,single regression analysis are also performed.
Key secondary outcomes	physical condition(body height,body weight,BMI,body surface area) blood data(ALT,feritin,HbA1c,high- sensitive CRP) liver biopsy data(NAFLD activity score, Brunt classification,fibrosis)

Base
Study type	Others,meta-analysis etc

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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1.patients who were suspected of having fatty liver and had liver biopsy (standard criteria; ALT >=31 IU/L) 2.patients who don't take oral hypoglycemic drug except alpha-GI,SU, glinide 3.healthy volunteers
Key exclusion criteria	persons who drink alcohol habitually (men >=30g/day, women >=20g/day)
Target sample size	55

Research contact person
Name of lead principal investigator	1st name Naoki Middle name Last name Kumashiro
Organization	Toho University School of Medicine
Division name	Division of diabetes,metabolism and endocrinology
Zip code	143-8541
Address	6-11-1 Omori-nishi,Ota-ku,Tokyo 143-8541,Japan
TEL	03-3762-4151(6560)
Email	naoki.kumashiro@med.toho-u.ac.jp

Public contact
Name of contact person	1st name Hiroyuki Middle name Last name Igarashi
Organization	Toho University School of Medicine
Division name	Division of diabetes,metabolism and endocrinology
Zip code	143-8541
Address	6-11-1 Omori-nishi,Ota-ku,Tokyo 143-8541,Japan
TEL	03-3762-4151(6560)
Homepage URL
Email	hiroyuki.igarashi@med.toho-u.ac.jp

Sponsor
Institute	Toho University School of Medicine Division of diabetes,metabolism and endocrinology
Institute
Department

Funding Source
Organization	Nothing
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	medical ethics committee of Toho University Omori Medical Center
Address	6-11-1 Omori-nishi,Ota-ku,Tokyo 143-8541,Japan
Tel	03-3762-4151(3132)
Email	omori.rinri@ext.toho-u.ac.jp

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	東邦大学医療センター大森病院（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 11 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	No longer recruiting
Date of protocol fixation	2018 Year 11 Month 12 Day
Date of IRB
Anticipated trial start date	2018 Year 11 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We collect data backward,and discuss problems considering patients' background and clinical condition.

Management information
Registered date	2018 Year 11 Month 15 Day
Last modified on	2019 Year 12 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039785