UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016379 |
|---|---|
| Receipt number | R000019026 |
| Scientific Title | Actual condition survey and examination of predictive factor for nonalcoholic fatty liver disease among the patients with metabolic diseases |
| Date of disclosure of the study information | 2015/01/29 |
| Last modified on | 2020/02/03 09:43:40 |
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Basic information
Public title
Actual condition survey and examination of predictive factor for nonalcoholic fatty liver disease among the patients with metabolic diseases
Acronym
Examination of actual condition and predictive factor for NAFLD
Scientific Title
Actual condition survey and examination of predictive factor for nonalcoholic fatty liver disease among the patients with metabolic diseases
Scientific Title:Acronym
Examination of actual condition and predictive factor for NAFLD
Region
| Japan |
Condition
Condition
Nonalcoholic fatty liver disease (NAFLD)
Nonalcoholic steatohepatitis (NASH)
Metabolic disease
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to identify prevalence of NAFLD and NASH among the outpatients with metabolic diseases. Next, we explore the associated factor between pathophysiology of NAFLD and NASH, and lifestyle and biochemical test and physical examination. Finally, we investigated the predictive factor for onset of NAFLD, NASH, metabolic diseases, cancer, arteriosclerotic disease in prospective study.
Basic objectives2
Others
Basic objectives -Others
exploration
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Identify prevalence of NAFLD among the patients with metabolic disease.
2.Explore the associated factor between pathophysiology of NAFLD, and lifestyle and biochemical test and physical examination.
3.Investigate the predictive factor for onset and exacerbating factor of NAFLD among the patients with metabolic disease.
4.Investigate the predictive factor for onset and exacerbating factor of metabolic diseases among the patients with metabolic disease among the patients with metabolic disease.
5.Investigate prevalence and associated factor of cancer onset among the patients with metabolic disease.
6.Investigate prevalence and associated factor of arteriosclerotic disease among the patients with metabolic disease.
Key secondary outcomes
1.Compare the diagnosability of NAFLD/NASH between associated factor of NAFLD in this study and score system of NAFLD/NASH
2.Evaluate the correlation between associated factor of NAFLD in this study and serum marker of NAFLD/NASH
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
1. Male and female over twenty years of age
2. Patients agree with participation
Key exclusion criteria
1. Patients with pregnancy and lactation
2. Patients with poor condition
3. Persons judged inappropriate for this study
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Teruki |
| Middle name | |
| Last name | Miyake |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Gastroenterology and Metabology
Zip code
7910295
Address
Toon City, Ehime, Japan
TEL
+81899605308
teruki-ygc@umin.ac.jp
Public contact
Name of contact person
| 1st name | Teruki |
| Middle name | |
| Last name | Miyake |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Gastroenterology and Metabology
Zip code
7910295
Address
Toon City, Ehime, Japan
TEL
+81899605308
Homepage URL
teruki-ygc@umin.ac.jp
Sponsor or person
Institute
Ehime University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN (JPN)
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Ehime University Hospital
Address
Shitsukawa Toon
Tel
089-960-5914
rinri@m.ehime-u.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
| 2015 | Year | 01 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective study
Management information
Registered date
| 2015 | Year | 01 | Month | 29 | Day |
Last modified on
| 2020 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019026
