UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035983 |
|---|---|
| Receipt number | R000040979 |
| Scientific Title | Prognostic significance of handgrip strength and body composition in patients with liver cirrhosis: a retrospective analysis |
| Date of disclosure of the study information | 2019/02/23 |
| Last modified on | 2019/02/23 13:30:24 |
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Basic information
Public title
Prognostic significance of handgrip strength and body composition in patients with liver cirrhosis: a retrospective analysis
Acronym
Handgrip strength and mortality
Scientific Title
Prognostic significance of handgrip strength and body composition in patients with liver cirrhosis: a retrospective analysis
Scientific Title:Acronym
Handgrip strength and mortality
Region
| Japan |
Condition
Condition
liver cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to assess the prognostic significance of handgrip strength in patients with liver cirrhosis.
Basic objectives2
Others
Basic objectives -Others
To evaluate the baseline clinical characteristics of male and female patients and the association between handgrip strength and body composition in each sex.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome of this study was all-cause mortality in patients with cirrhosis.
Key secondary outcomes
Secondary outcomes were the baseline clinical characteristics of male and female patients and the association between handgrip strength and body composition in each sex.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
liver cirrhosis
Key exclusion criteria
liver transplantation; uncontrolled HCC; other malignancies; orthopedic and/or neurological diseases that could affect HGS measurement; bedrest; sedentary lifestyle; severe endocrine disease; active ongoing infection and severe comorbidities including heart, respiratory and/or renal failure.
Target sample size
882
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Shiraki |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Gastroenterology/Internal Medicine
Zip code
Address
yanagido 1-1, gifu
TEL
058-230-6308
ichi-nai@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsunori hanai |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Gastroenterology/Internal Medicine
Zip code
Address
yanagido 1-1, gifu
TEL
058-230-6308
Homepage URL
hanai@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2019 | Year | 02 | Month | 23 | 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
Completed
Date of protocol fixation
| 2011 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 08 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Measurement of handgrip strength was carried out using a Jamar dynamometer. Body composition, including skeletal muscle and adipose tissue, was estimated using computed tomography imaging. Sex-stratified multivariate analysis was carried out to identify the predictors of mortality in cirrhotic patients.
Management information
Registered date
| 2019 | Year | 02 | Month | 23 | Day |
Last modified on
| 2019 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040979
