UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044662 |
|---|---|
| Receipt number | R000051006 |
| Scientific Title | Study of perioperative glucose metabolism and development of novel treatment for sarcopenia patients using artificial pancreas |
| Date of disclosure of the study information | 2021/07/01 |
| Last modified on | 2021/06/25 18:06:32 |
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Basic information
Public title
Study of perioperative glucose metabolism and development of novel treatment for sarcopenia patients using artificial pancreas
Acronym
Study of perioperative glucose metabolism and development of novel treatment for sarcopenia patients using artificial pancreas
Scientific Title
Study of perioperative glucose metabolism and development of novel treatment for sarcopenia patients using artificial pancreas
Scientific Title:Acronym
Study of perioperative glucose metabolism and development of novel treatment for sarcopenia patients using artificial pancreas
Region
| Japan |
Condition
Condition
Patients who are going to be undergone digestive surgery
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify perioperative glucose metabolism and new therapeutic methods in sarcopenia patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose variability
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Group A (non Sarcopenia)
Interventions/Control_2
Group B (Sarcopenia)
Interventions/Control_3
Group C (Sarcopenia patients received preoperative nutrition therapy and exercise therapy)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are going to be undergone digestive surgery
Key exclusion criteria
none
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kazuhio |
| Middle name | |
| Last name | Hanazaki |
Organization
Kochi Medical School
Division name
Department of Surgery
Zip code
7838505
Address
Kohasu, Okocho, Nankoku, Kochi
TEL
0888802370
im-31@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | munekage |
Organization
Kochi Medical School
Division name
Department of Surgery
Zip code
7838505
Address
Kohasu, Okocho, Nankoku, Kochi
TEL
0888802370
Homepage URL
m-munekage@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board of Kochi Medical School
Address
Kohasu, Okocho, Nankoku, Kochi
Tel
088-880-2180
is21@kochi-u.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
| 2021 | Year | 07 | 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
| 2021 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 25 | Day |
Last modified on
| 2021 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051006
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
