UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034901
Receipt No. R000039785
Scientific Title development of new measurement methods of liver fat volume by magnetic resonance imaging
Date of disclosure of the study information 2018/11/15
Last modified on 2018/11/15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Naoki Kumashiro
Organization Toho University School of Medicine
Division name Division of diabetes,metabolism and endocrinology
Zip code
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
Middle name
Last name Hiroyuki Igarashi
Organization Toho University School of Medicine
Division name Division of diabetes,metabolism and endocrinology
Zip code
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
Address
Tel
Email

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
2018 Year 11 Month 15 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.