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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034902
Receipt No. R000039782
Scientific Title comprehensive analysis of factors which decide hepatic insulin sensitivity in Japanese non-alcoholic fatty liver disease
Date of disclosure of the study information 2018/11/19
Last modified on 2018/12/10

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Basic information
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
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 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

Assessment
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)

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
(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

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 19 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 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
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 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039782

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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