UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study on nutritional assessment in patients with chronic liver disease using skeletal muscle volume and renal blood flow.
Title of the study (Brief title)	The study on nutritional assessment in patients with chronic liver disease using skeletal muscle volume and renal blood flow.
Region	Japan

Condition
Condition	Liver cirrhosis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate nutritional statement in cirrhotic patients by measuring diameter and cross sectional area of iliopsoas muscle and renal blood flow using ultrasound examination.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Investigation of the relationship between clinical findings and iliopsoas muscle diameter and cross sectional area.
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with liver cirrhosis and patients without liver cirrhosis as a control
Key exclusion criteria	Patients with malignant tumor Patients who can't walk without support Patients with severe heart, lung, renal disease Pregnancy Patients who have an egg allergy Patients with one kidney or post renal transplantation
Target sample size	300

Research contact person
Name of lead principal investigator	Maruyama Hitoshi
Organization	Chiba University Hospital
Division name	Gastroenterology department
Address	1-8-1, Inohana, Chuou-ku, Chiba, Japan
TEL	043-226-2083
Email	maru-cib@umin.ac.jp

Public contact
Name of contact person	Maruyama Hitoshi
Organization	Chiba University Hospital
Division name	Gastroenterology department
Address	1-8-1, Inohana, Chuou-ku, Chiba, Japan
TEL	043-226-2083
Homepage URL
Email	maru-cib@umin.ac.jp

Sponsor
Institute	Chiba University Hospital, Gastroenterology Department
Institute
Department

Funding Source
Organization	Chiba University Hospital, Gastroenterology Department
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	2016 Year 11 Month 23 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2014 Year 12 Month 15 Day
Anticipated trial start date	2015 Year 01 Month 01 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	Nutritional assessment of cirrhotic patients by using ultrasound examination, especially diagnosis of sarcopenia

Management information
Registered date	2016 Year 11 Month 23 Day
Last modified on	2016 Year 11 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028708