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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044662
Receipt No. 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

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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
Email 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
Email m-munekage@kochi-u.ac.jp

Sponsor
Institute Kochi Medical School
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051006

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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