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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030755
Receipt No. R000035113
Scientific Title Analysis of sarcopenia in patients with liver disorder
Date of disclosure of the study information 2018/01/10
Last modified on 2018/01/10

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Basic information
Public title Analysis of sarcopenia in
patients with liver disorder
Acronym sarcopenia in
patients with liver disorder
Scientific Title Analysis of sarcopenia in
patients with liver disorder
Scientific Title:Acronym sarcopenia in
patients with liver disorder
Region
Japan

Condition
Condition Patients with liver disorder
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To analyze the frequency and the associated factors of sarcopenia in patients with
liver order
Basic objectives2 Others
Basic objectives -Others To analyze the frequency and the associated factors of sarcopenia in patients with
liver order
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To investigate Frequency of sarcopenia in
Patients with liver disorder
Key secondary outcomes 1To investigate association between
PMI and Body composition analysis
2 To investigate cause of liver
disease in patients with Sarcopenia
3 To investigate the effects of BCAA,
carnitine and diuretic drug
administration on sacropenia

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 patients with liver disorder
2 20 year old or more than 20 years old
3 patients who agree to paticipate this
study or disagree to paticipate this study.
Key exclusion criteria patients judged to be inappropriate to participate in the study by the primary physician
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Ogawa
Organization Graduate School of Medicine,
Hokkaido University
Division name Department of Gastroenterology and Hepatology
Zip code
Address North 15, West 7, Kita-ku, Sapporo, Hokkaido
TEL 011-716-2111
Email k-ogawa@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Goki Suda
Organization Graduate School of Medicine, Hokkaido University
Division name Department of Gastroenterology and Hepatology
Zip code
Address North 15, West 7, Kita-ku, Sapporo, Hokkaido
TEL +81-11-716-1161
Homepage URL
Email gsudgast@pop.med.hokudai.ac.jp

Sponsor
Institute Hokkaido University,
Department of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization Hokkaido University,
Department of Gastroenterology and Hepatology
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
Address
Tel
Email

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 01 Month 10 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
2017 Year 03 Month 23 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1 clinical factors (age, sex, hight, weight, BCAA administration, carnitine administration,presence of HCC, presence of ascites fluid e.g.)
2 blood count
3 biochemical examination (T-bil, Alb,AST,ALT,GTP,ALP,TP,LDH,Cr,BUN,Na,K,Cl,IGF-1,VitaminD PT% e.g.)
4 amount of skeltal muscle mass

Management information
Registered date
2018 Year 01 Month 10 Day
Last modified on
2018 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035113

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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