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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025790
Receipt No. R000029376
Scientific Title Efficacy and nutritional status of InBodyTM in diagnosis of presarcopenia and sarcopenia
Date of disclosure of the study information 2017/01/21
Last modified on 2017/07/24

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Basic information
Public title Efficacy and nutritional status of InBodyTM in diagnosis of presarcopenia and sarcopenia
Acronym Efficacy and nutritional status of InBodyTM in diagnosis of presarcopenia and sarcopenia
Scientific Title Efficacy and nutritional status of InBodyTM in diagnosis of presarcopenia and sarcopenia
Scientific Title:Acronym Efficacy and nutritional status of InBodyTM in diagnosis of presarcopenia and sarcopenia
Region
Japan

Condition
Condition Chronic liver disease
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate nutritional status by exercise therapy and component for liver failure nutritional formula for cases of chronic liver failure with hepatic encephalopathy among patients with chronic liver disease. We also examine whether exercise therapy and component for liver failure nutritional formula administration can inhibit development and progression to sarcopenia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate the prevalence of presarcopenia and sarcopenia in patients with chronic liver disease
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 Patients with chronic liver disease who are 20 or more years old

Patients with ECOG PS 0 or 1

Patient who is a chronic liver disease patient and has participated in this study fully enough to explain themselves before the start of the research and obtained consent form by themselves.

Patients who are pregnant or nursing and who have no possibility or willingness to become pregnant (perform a pregnancy test if there is suspected pregnancy)
Key exclusion criteria 1)Patients who actually have hepatic encephalopathy with coma classification II or more.
2)Patients with congenital branched-chain amino acid metabolism abnormalities.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name masatoshi kudo
Organization Department of Gastroenterology and Hepatology Kindai University Faculty of Medicine
Division name Department of Gastroenterology and Hepatology Kindai University Faculty of Medicine
Zip code
Address 377-2 Ohno-higashi, Osaka-sayama, Osaka 589-8511, Japan.
TEL 072-366-0221
Email m-kudo@med.kindai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masashi Kono
Organization Department of Gastroenterology and Hepatology Kindai University Faculty of Medicine
Division name Department of Gastroenterology and Hepatology Kindai University Faculty of Medicine
Zip code
Address 377-2 Ohno-higashi, Osaka-sayama, Osaka 589-8511, Japan.
TEL 072-366-0221
Homepage URL
Email kono@med.kindai.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology Kindai University Faculty of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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 近畿大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 21 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 Enrolling by invitation
Date of protocol fixation
2016 Year 09 Month 07 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information <member of a research project>
Masatoshi Kudo
Naoshi Nishida
Kazuomi Ueshima
Satoru Hagiwara
Yasunori Minami
Masahiro Takita
Hiroshi Ida
Norihisa Yada
Tadaaki Arizumi
Hirokazu Chishina
Masashi Kono
Tomohiro Minami
Mina Iwanishi

Management information
Registered date
2017 Year 01 Month 21 Day
Last modified on
2017 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029376

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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