UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035127 |
|---|---|
| Receipt number | R000019143 |
| Scientific Title | The cohort study for live-style associated liver disease |
| Date of disclosure of the study information | 2018/12/05 |
| Last modified on | 2020/11/02 12:27:59 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
Fatty Liver
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
Others
Basic objectives -Others
Epidemiology of fatty liver.
Trial characteristics_1
Trial characteristics_2
Developmental phase
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Receiving Fibro scan.
Key exclusion criteria
Refusal or lacks capacity to give informed consent to participate in the trial.
Target sample size
2000
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
602-8566
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 | Masahide |
| Middle name | |
| Last name | Hamaguchi |
Organization
Kyoto Prefectural University of Medicine Graduate School of Medical Science
Division name
Department of Endocrinology and Metabolism
Zip code
602-8566
Address
465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku
TEL
+81-75-251-5506
Homepage URL
mhama@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine Graduate School of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
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
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 05 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S1499267120300770?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S1499267120300770?via%3Dihub
Number of participants that the trial has enrolled
246
Results
LSM was associated with changes in UAE (r<0.27,p<0.005). Multiple regression analysis demonstrated that LSM was associated with change in UAE (b=0.28,p<0.015) after adjusting for co-variate.
Results date posted
| 2020 | Year | 08 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 03 | Month | 23 | Day |
Baseline Characteristics
Mean (standard deviation) data were as follows: age, 63.3 (12.1) years;body mass index, 25.4 (4.3)kg/m2; controlled attenuation parameter, 273.1 (53.0) dB/m; and LSM, 6.2 (3.4) kPa. Median UAE value(interquartile range) was 16 (6 to 43) mg/g creatinine.
Participant flow
Our study enrolled 246 patients (140 men and 106 women).Among these 246 patients, 72 men and 31 women were excluded.Thus, 143 patients (68 men and 75 women) were included in this study. Twenty-six patients (9 men and 17 women) did not undergo follow-up examination. Moreover, 12 patients with kidney disease with at least stage 3 nephropathy were excluded from the study.Thus, we investigated 105 patients (52 men and 53 women)
Adverse events
No
Outcome measures
The association between LSM with change in UAE.
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
Prospective and retrospective study.
Outpatient in University Hospital, Kyoto Prefectural University of Medicine
First subject in 2015/03/02
Last Subject in 2025/3/31
Management information
Registered date
| 2018 | Year | 12 | Month | 04 | 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=R000019143
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
