UMIN-CTR Clinical Trial

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

Diabetes,Non-alcoholic fatty liver
disease

Classification by specialty

Hepato-biliary-pancreatic medicine

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Toho University School of Medicine
Division of diabetes,metabolism and
endocrinology

Institute

Department

Personal name

Organization

Nothing

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東邦大学医療センター大森病院（東京都）

Date of disclosure of the study information

2018

Year

11

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

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

Registered date

2018

Year

11

Month

15

Day

Last modified on

2019

Year

12

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039785