UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025790
Receipt number 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 2024/01/27 12:39:51

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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 masatoshi
Middle name
Last name 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

589-0014

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 masashi
Middle name
Last name 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

589-0014

Address

377-2 Ohno-higashi, Osaka-sayama, Osaka 589-8511, Japan.

TEL

09084560416

Homepage URL


Email

kono@med.kindai.ac.jp


Sponsor or person

Institute

Department of Gastroenterology and Hepatology Kindai University Faculty of Medicine

Institute

Department

Personal name



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

Department of Gastroenterology and Hepatology Kindai University Faculty of Medicine

Address

377-2 Ohno-higashi, Osaka-sayama, Osaka 589-8511, Japan.

Tel

072-366-0221

Email

kono@med.kindai.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

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

2018 Year 08 Month 30 Day

Anticipated trial start date

2017 Year 01 Month 21 Day

Last follow-up date

2030 Year 01 Month 21 Day

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

2024 Year 01 Month 27 Day



Link to view the page

Value
https://center6.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