UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000024960
Receipt No. R000028708
Scientific Title The study on nutritional assessment in patients with chronic liver disease using skeletal muscle volume and renal blood flow.
Date of disclosure of the study information 2016/11/23
Last modified on 2016/11/23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The study on nutritional assessment in patients with chronic liver disease using skeletal muscle volume and renal blood flow.
Acronym The study on nutritional assessment in patients with chronic liver disease using skeletal muscle volume and renal blood flow.
Scientific Title The study on nutritional assessment in patients with chronic liver disease using skeletal muscle volume and renal blood flow.
Scientific Title:Acronym 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
1st name
Middle name
Last name Maruyama Hitoshi
Organization Chiba University Hospital
Division name Gastroenterology department
Zip code
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
1st name
Middle name
Last name Maruyama Hitoshi
Organization Chiba University Hospital
Division name Gastroenterology department
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
Date of protocol fixation
2014 Year 12 Month 15 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.