UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019401 |
|---|---|
| Receipt number | R000021733 |
| Scientific Title | The measurement of liver stiffness and hepatic steatosis in patients with anorexia nervosa. |
| Date of disclosure of the study information | 2015/10/19 |
| Last modified on | 2024/03/13 10:53:03 |
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Basic information
Public title
The measurement of liver stiffness and hepatic steatosis in patients with anorexia nervosa.
Acronym
Liver stiffness and hepatic steatosis in anorexia nervosa.
Scientific Title
The measurement of liver stiffness and hepatic steatosis in patients with anorexia nervosa.
Scientific Title:Acronym
Liver stiffness and hepatic steatosis in anorexia nervosa.
Region
| Japan |
Condition
Condition
anorexia nervosa
Classification by specialty
| Hepato-biliary-pancreatic medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate liver stiffness and hepatic steatosis using Fibroscan in Japanese patients with anorexia nervosa.
Basic objectives2
Others
Basic objectives -Others
To assess the role of liver stiffness in the pathogenesis of anorexia nervosa.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
liver stiffness
Key secondary outcomes
hepatic steatosis
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Liver stiffness and steatosis will be evaluated by Fibroscan in patients with anorexia nervosa, basically on admission and just before discharge.
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
adult patients with anorexia nerovsa
Key exclusion criteria
non-agree patients, inappropriate patients.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Ueno |
Organization
Yamagata University Faculty of Medicine,
Division name
Gastreenterology
Zip code
9909585
Address
2-2-2 Iidanishi, Yamagata
TEL
023-628-5309
y-ueno@med.id.yamagata-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Ueno |
Organization
Yamagata University Faculty of Medicine
Division name
Gastroenterology
Zip code
9909585
Address
2-2-2 Iidanishi, Yamagata
TEL
023-628-5309
Homepage URL
http://www.id.yamagata-u.ac.jp/Tiken/
y-ueno@med.id.yamagata-u.ac.jp
Sponsor or person
Institute
Yamagata University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Non profitable funding to Yamagata University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamagata University Faculty of Medicine
Address
2-2-2 Iidanishi, Yamagata,
Tel
0236285523
ikekenkyu@jm.kj.yamagata-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
山形大学医学部附属病院（山形県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | 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
| Delay expected |
Results Delay Reason
Delay for the data analysis.
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
| 2015 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 19 | Day |
Last modified on
| 2024 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021733
