UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025543
Receipt number R000029406
Scientific Title Investigation of roles of ghrelin in the development of sarcopenia in cirrhotic patients
Date of disclosure of the study information 2017/04/01
Last modified on 2024/01/11 10:09:49

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Basic information

Public title

Investigation of roles of ghrelin in the development of sarcopenia in cirrhotic patients

Acronym

Relationship between sarcopenia and ghrelin

Scientific Title

Investigation of roles of ghrelin in the development of sarcopenia in cirrhotic patients

Scientific Title:Acronym

Relationship between sarcopenia and ghrelin

Region

Japan


Condition

Condition

cirrhotic patients

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigation of roles of ghrelin in the development of sarcopenia

Basic objectives2

Others

Basic objectives -Others

Investigation of association between ghrelin and liver function

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Relationship between sarcopenia and ghrelin

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

equal or more than 20-year old

Key exclusion criteria

less than 20-year old

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Masatoshi
Middle name
Last name Ishigami

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

4668550

Address

65 Tsuruma-cho, Showa-ku, Nagoya

TEL

052-744-2169

Email

masaishi@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name Ishizu
Middle name
Last name Yoji

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

4668550

Address

65 Tsuruma-cho, Showa-ku, Nagoya

TEL

052-744-2169

Homepage URL


Email

y-ishizu@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University

Institute

Department

Personal name



Funding Source

Organization

Nagoya University

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

Nagoya University Graduate School of Medicine

Address

turumai-sho 65, showa-ku

Tel

0527442169

Email

iga-shinsa@adm.nagoya-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



Other administrative information

Date of disclosure of the study information

2017 Year 04 Month 01 Day


Related information

URL releasing protocol

None

Publication of results

Unpublished


Result

URL related to results and publications

None

Number of participants that the trial has enrolled

80

Results

Appetite is significantly reduced in patients with sarcopenia

Results date posted

2024 Year 01 Month 11 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Patients with chronic liver disease

Participant flow

no

Adverse events

no

Outcome measures

appetite (VAS scale)

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2017 Year 02 Month 01 Day

Date of IRB

2017 Year 03 Month 01 Day

Anticipated trial start date

2017 Year 03 Month 01 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

No


Management information

Registered date

2017 Year 01 Month 05 Day

Last modified on

2024 Year 01 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029406


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name