UMIN-CTR Clinical Trial

Public title

comprehensive analysis of factors which
decide hepatic insulin sensitivity in
Japanese non-alcoholic fatty liver disease

Acronym

comprehensive analysis of factors which
decide hepatic insulin sensitivity in
Japanese non-alcoholic fatty liver disease

Scientific Title

comprehensive analysis of factors which
decide hepatic insulin sensitivity in
Japanese non-alcoholic fatty liver disease

Scientific Title:Acronym

comprehensive analysis of factors which
decide hepatic insulin sensitivity in
Japanese non-alcoholic fatty liver disease

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 it is known that it can
be a risk factor of diabetes. However,
evaluation of hepatic insulin resistance
has high speciality and imposes severe
timewise and economical burden now. Thus,
we planned this research to investigate
factors associating the level of hepatic
insulin resistance,also,to find the
treatment target through factors which
relate to hepatic insulin resistance in
Japanese NAFLD.
Outcomes of this research leads to more accurate medical evaluation of disorder
of glucose metabolism in each case and
appropriate decision of treatment method.

Basic objectives2

Others

Basic objectives -Others

To assess various clinical factors in NAFLD patients

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

The comprehensive analysis which evaluate
the association between % suppression of
EGP and all assessed indices were
performed.
(e.g. correlation coefficient of
Pearson and Spearman, and single and
multiple regression analysis)

general items(age,body height,body weight,
BMI,body surface area,having diabetes,
taking oral hypoglycemic drug)
(oral hypoglycemic drug:alpha-GI,SU,
glinide)

complete blood count(WBC,RBC,Ht,PLT)

blood biochemistry(ALT,feritin,high-
molecule adiponectin,collagen4,HbA1c,
hyaluronic acid,C peptide,cortisol,
high-sensitive CRP,urine 8OHdG)

hyperinsulinemic-euglycemic clamp
(fasting blood glucose,steady state blood
glucose,fasting blood insulin,steady state
blood insulin,fasting blood insulin times
basal endogenous glucose production;basal
EGP,steady state glucose infusion rate
;ssGIR,steady state glucose uptake rate
;ssRd,glucose uptake change rate,basal
blood free fatty acid,steady state blood
free fatty acid,free fatty acid change
rate)
(basal EGP,ssGIR,ssRd are corrected by
lean body weight.)

DEXA(fat ratio,lean body weight,whole
muscle weight/the square of body height)

CT(whole lipid area,visceral fat area,
subcutaneous fat area,body circumference)

Proton MRS(intramyocellular lipid
content,extramyocellular lipid content,
intra hepatic lipid)

MRI(hepatic fat ratio,liver volume,
liver fat volume,lean hepatic volume;all
are corrected by body surface area.)

QOL content(BDI2,Wellbeing)(research by
questionnaire)

sleep content(MEQ,pittsburgh,sleep time)
(research by questionnaire)

exercise content(volume of physical
activity,total daily energy expenditure)
(measured by medical pedometer)

diet (total dietary intake,volume of
alcohol intake,carbo,protein and fat
intake ratio)
(assessed by questionnaire)

liver biopsy(fat,intralobular
inflammmation,balooning,NAS:NAFLD
Activity Score,fibrosis)

Key secondary outcomes

comprehensive analysis of gene expression
(microarray)

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
(standard criteria; ALT>=31 IU/L)

2.patients who don't take oral
hypoglycemic drugs except alpha-GI,SU,
glinide

Key exclusion criteria

1.cases whose intra hepatic lipid are 5%
and under in 1H-MRS
(diagnosis criteria of NAFLD)
2.persons who drink alcohol habitually
(men >=30g/day,women >=20g/day)
3.cases whose NAS(NAFLD Activity Score)
is 5 point and over in liver biopsy
(diagnosis criteria of NASH)
(However,2 cases with no liver biopsy
can't deny NASH.)

Target sample size

36

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

19

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

16

Day

Date of IRB

Anticipated trial start date

2018

Year

11

Month

16

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=R000039782