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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000020303
Receipt No. R000019144
Scientific Title The cohort study for live-style associated liver disease
Date of disclosure of the study information 2015/12/22
Last modified on 2019/12/10

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Basic information
Public title The cohort study for live-style associated liver disease
Acronym The cohort study for live-style associated liver disease
Scientific Title The cohort study for live-style associated liver disease
Scientific Title:Acronym The cohort study for live-style associated liver disease
Region
Japan

Condition
Condition NAFLD
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of the study is to obtain the clinical features of subjects with non-alcoholic fatty liver disease. In this study, we perform a prospective and a retrospective cohort study aiming to prevent the progression of nonalcoholic steatohepatitis (NASH). For the purpose, we analyze the clinical data registered in the study and find clinical features associated with the progression of nonalcoholic steatohepatitis (NASH) and find clinical features, by which we can predict a high risk group of NASH.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes The change of the controlled attenuation parameter (CAP) and liver stiffness measurement (LSM) determined by FibroScan (Echosens, Paris, France).
Key secondary outcomes

Base
Study type Observational

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 We included the patients who underwent both elastography and bioelectrical impedance body composition evaluations.
Key exclusion criteria We excluded the patients without NAFLD, the definition is described below. Exclusion criteria was set as no data of lever stiffness measurement, or no data of bio impedance analysis. After initial registration, the patients, with two or more elastography and bioelectrical impedance body composition evaluations, were extracted.
Target sample size 72

Research contact person
Name of lead principal investigator
1st name Michiaki
Middle name
Last name Fukui
Organization Kyoto Prefectural University of Medicine Graduate School of Medical Science
Division name Department of Endocrinology and Metabolism
Zip code 6028566
Address 465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku
TEL +81-75-251-5505
Email michiaki@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name Takafumi
Middle name
Last name Osaka
Organization Kyoto Prefectural University of Medicine Graduate School of Medical Science
Division name Department of Endocrinology and Metabolism
Zip code 6028566
Address 465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku
TEL +81-75-251-5505
Homepage URL
Email tak-1314@koto.kpu-m.ac.jp

Sponsor
Institute Department of Endocrinology and Metabolism
Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization AstraZeneca
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyoto Prefectural University of Medicine, Clinical Research Review Board
Address Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566
Tel 075-251-5337
Email rinri@koto.kpu-m.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 ESR-14-10099
Org. issuing International ID_1 AstraZeneca
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 京都府立医科大学附属病院

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 22 Day

Related information
URL releasing protocol https://www.mdpi.com/2077-0383/8/12/2175
Publication of results Published

Result
URL related to results and publications https://www.mdpi.com/2077-0383/8/12/2175
Number of participants that the trial has enrolled 143
Results
Multiple regression analyses demonstrated that change in fat-to-muscle mass ratio was associated with the rate of change in CAP (beta= 0.38, p < 0.001) or rate of change in LSM (beta= 0.21, p = 0.026).

Results date posted
2019 Year 12 Month 10 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2019 Year 12 Month 09 Day
Baseline Characteristics
Mean age was 63.5(12.2) years, the BMI was 25.4(4.4) kg/m2, the SMI was 7.1(1.2) kg/m2, the body fat percentage was 31.1(8.2)%, the HbA1c was 7.5(1.1)%, the AST was 29.8(18.6)IU/L, the ALT was 34.9(30.0) IU/L, Fib-4 index 1.67(0.84), the CAP was 273.4(53.5) dB/m, and the LSM 6.3(3.4) kPa.
Participant flow
Of the remaining 143 patients (68 men and 75 women), 26 (nine men and 17 women) did not receive a 1-year follow-up examination.
A total of 117 patients (59 men and 58 women) were included in the final analysis. 
Adverse events
None
Outcome measures
BMI, SMI, the body fat percentage, HbA1c, AST, ALT, Fib-4 index, CAP, LSM, fat-to-muscle mass ratio.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2015 Year 03 Month 02 Day
Date of IRB
2015 Year 03 Month 02 Day
Anticipated trial start date
2015 Year 03 Month 02 Day
Last follow-up date
2016 Year 08 Month 31 Day
Date of closure to data entry
2017 Year 12 Month 15 Day
Date trial data considered complete
2017 Year 12 Month 19 Day
Date analysis concluded
2019 Year 07 Month 16 Day

Other
Other related information Observational study
Study periods 52 weeks.
Outpatient in University Hospital, Kyoto Prefectural University of Medicine
First subject in 2015/03/02
Last Subject in 2016/8/31

Management information
Registered date
2015 Year 12 Month 21 Day
Last modified on
2019 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=R000019144

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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