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
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
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
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
