UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024960
Receipt number 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 10:42:59

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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 or person

Institute

Chiba University Hospital, Gastroenterology Department

Institute

Department

Personal name



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

Value
https://center6.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