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
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
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
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
