UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of sarcopenia in patients with liver disorder
Title of the study (Brief title)	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	Koji Ogawa
Organization	Graduate School of Medicine, Hokkaido University
Division name	Department of Gastroenterology and Hepatology
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	Goki Suda
Organization	Graduate School of Medicine, Hokkaido University
Division name	Department of Gastroenterology and Hepatology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 03 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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