UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prognostic significance of handgrip strength and body composition in patients with liver cirrhosis: a retrospective analysis
Title of the study (Brief title)	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	Makoto Shiraki
Organization	Gifu University Graduate School of Medicine
Division name	Department of Gastroenterology/Internal Medicine
Address	yanagido 1-1, gifu
TEL	058-230-6308
Email	ichi-nai@gifu-u.ac.jp

Public contact
Name of contact person	Tatsunori hanai
Organization	Gifu University Graduate School of Medicine
Division name	Department of Gastroenterology/Internal Medicine
Address	yanagido 1-1, gifu
TEL	058-230-6308
Homepage URL
Email	hanai@gifu-u.ac.jp

Sponsor
Institute	Gifu University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040979