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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035952
Receipt No. R000040914
Scientific Title A Study for evaluating the effectiveness of nutrition therapy in patients with cirrhosis with impaired glucose tolerance using continuous glucose monitoring and body composition analyzer
Date of disclosure of the study information 2019/03/01
Last modified on 2019/02/20

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Basic information
Public title A Study for evaluating the effectiveness of nutrition therapy in patients with cirrhosis with impaired glucose tolerance using continuous glucose monitoring and body composition analyzer
Acronym A Study for evaluating the effectiveness of nutrition therapy in patients with cirrhosis with impaired glucose tolerance
Scientific Title A Study for evaluating the effectiveness of nutrition therapy in patients with cirrhosis with impaired glucose tolerance using continuous glucose monitoring and body composition analyzer
Scientific Title:Acronym A Study for evaluating the effectiveness of nutrition therapy in patients with cirrhosis with impaired glucose tolerance
Region
Japan

Condition
Condition Cirrhosis with impaired glucose tolerance
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effectiveness of nutrition therapy using continuous glucose monitoring and a body composition analyzer for patients with cirrhosis complicating impaired glucose tolerance.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To assess the changes of blood glucose level by nutrition therapy in cirrhotic patients with impaired glucose tolerance.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 To evaluate the continuous blood glucose level in the cirrhotic patient with impaired glucose tolerance before and after 2 weeks of the nutrition therapy.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1 20 years or older
2 Have a histologically or clinically confirmed diagnosis of liver cirrhosis
3 Have impaired glucose tolerance
4 Informed and consent
5 Considered as a adaptation by the principal investigator
Key exclusion criteria 1 Pacemaker
2 Another glucose monitoring
3 Pregnant
4 Cancer
5 Tendency to hemorrhages
6 Considered as a impropriety by the principal investigator
7 Withdraw the consent
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kawata, Kazuhito
Organization Hamamatsu University School of Medicine
Division name Second department of internal medicine
Zip code
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL 053-435-2262
Email kawata@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noritake, Hidenao
Organization Hamamatsu University School of Medicine
Division name Second department of internal medicine
Zip code
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL 053-435-2262
Homepage URL
Email noritake@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Self funding
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
2019 Year 03 Month 01 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 Preinitiation
Date of protocol fixation
2019 Year 02 Month 15 Day
Date of IRB
Anticipated trial start date
2019 Year 03 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

Management information
Registered date
2019 Year 02 Month 20 Day
Last modified on
2019 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040914

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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