UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020303 |
|---|---|
| Receipt number | 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 | 2020/11/02 12:27:31 |
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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
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
tak-1314@koto.kpu-m.ac.jp
Sponsor or person
Institute
Department of Endocrinology and Metabolism
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
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
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
Completed
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
| 2020 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019144
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