UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048265 |
|---|---|
| Receipt number | R000055002 |
| Scientific Title | Biomarker reserch for prediction to resolve nonalcoholic liver diseases by bariatric surgery |
| Date of disclosure of the study information | 2022/07/11 |
| Last modified on | 2022/07/04 13:51:21 |
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Basic information
Public title
Biomarker reserch for prediction to resolve nonalcoholic liver diseases by bariatric surgery
Acronym
Biomarker reserch for prediction to resolve nonalcoholic liver diseases by bariatric surgery
Scientific Title
Biomarker reserch for prediction to resolve nonalcoholic liver diseases by bariatric surgery
Scientific Title:Acronym
Biomarker reserch for prediction to resolve nonalcoholic liver diseases by bariatric surgery
Region
| Japan |
Condition
Condition
Nonalcoholic fatty liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To detect biomarkers which predict the
resolution of nonalcoholic fatty liver disease by bariatric surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The serum cytokine profiles 12weeks after bariatric surgery
Key secondary outcomes
The serum cytokine profiles 24 and 48weeks after bariatric surgery
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients to have bariatric surgery with BMI>=32.5kg/m2 medicine treatment-refractory morbid obesity.
Key exclusion criteria
Patients with a medical history of gastric surgery or uncontrolled mental illness, drug addiction and alcohol use disorder
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Nakamoto |
Organization
Keio University, School of Medicine
Division name
Division of Gastroenterology and Hepatology
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-ku, Tokyo
TEL
+81-3-3353-1211
nobuhiro@z2.keio.jp
Public contact
Name of contact person
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Nakamoto |
Organization
Keio University, School of Medicine
Division name
Division of Gastroenterology and Hepatology
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-ku, Tokyo
TEL
+81-3-3353-1211
Homepage URL
nobuhiro@z2.keio.jp
Sponsor or person
Institute
Keio University, School of Medicine
Division of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Keio University, School of Medicine
Division of Gastroenterology and Hepatology
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
Keio University, School of Medicine Division of Gastroenterology and Hepatology
Address
35 Shinanomachi Shinjuku-ku, Tokyo
Tel
+81-3-3353-1211
nobuhiro@z2.keio.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
| 2022 | Year | 07 | Month | 11 | 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
| 2022 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluation of liver fibrosis by liver biopsy , liver erastography and non invasive serum scoring system
Management information
Registered date
| 2022 | Year | 07 | Month | 04 | Day |
Last modified on
| 2022 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055002
