UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035952 |
|---|---|
| Receipt number | 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 | 2021/02/25 19:20:39 |
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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 | Kazuhito |
| Middle name | |
| Last name | Kawata |
Organization
Hamamatsu University School of Medicine
Division name
Second department of internal medicine
Zip code
4313192
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL
053-435-2262
kawata@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hidenao |
| Middle name | |
| Last name | Noritake |
Organization
Hamamatsu University School of Medicine
Division name
Second department of internal medicine
Zip code
4313192
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL
053-435-2262
Homepage URL
noritake@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
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
Clinical Research Review Board of Hamamatsu University School of Medicine
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu, Shizuoka
Tel
053-435-2680
rinri@hama-med.ac.jp
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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
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
| 2021 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040914
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
