UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048787 |
|---|---|
| Receipt number | R000053918 |
| Scientific Title | Optimal dose of long-acting insulin analogue for withdrawal of artificial pancreas after hepatectomy -pilot study- |
| Date of disclosure of the study information | 2022/08/30 |
| Last modified on | 2022/08/29 21:30:39 |
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Basic information
Public title
Appropriate Dosage of Long-acting Insulin at the Time of Artificial Pancreas Withdrawal
Acronym
Appropriate Dosage of Long-acting Insulin at the Time of Artificial Pancreas Withdrawal
Scientific Title
Optimal dose of long-acting insulin analogue for withdrawal of artificial pancreas after hepatectomy -pilot study-
Scientific Title:Acronym
Optimal dose of long-acting insulin analogue for withdrawal of artificial pancreas after hepatectomy -pilot study-
Region
| Japan |
Condition
Condition
liver cancer, Diabetes
Classification by specialty
| Endocrinology and Metabolism | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To find an appropriate formula to determine the amount of long-acting insulin at the time of artificial pancreas withdrawal.
Basic objectives2
Others
Basic objectives -Others
Appropriate long-acting insulin dose at the time of artificial pancreas withdrawal
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Approximate formula for determining basal insulin dose at the time of artificial pancreas withdrawal
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 55 | years-old | <= |
Age-upper limit
| 82 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A case of partial/ lobectomy of the liver with bedside type artificial pancreas STG-55 (Nikkiso)
Key exclusion criteria
Cases of withdrawal from artificial pancreas
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | Atsuhito |
| Middle name | |
| Last name | Tone |
Organization
Okayama Saiseikai General Hospital
Division name
Department of Internal Medicine, Diabetes Center
Zip code
700-8511
Address
2-25 Kokutai-cho, Kita-ku, Okayama City
TEL
086-252-2211
aitone@ms1.megaegg.ne.jp
Public contact
Name of contact person
| 1st name | Toshihisa |
| Middle name | |
| Last name | Tahara |
Organization
Okayama Saiseikai General Hospital
Division name
Department of Internal Medicine, Diabetes Center
Zip code
700-8511
Address
2-25 Kokutai-cho, Kita-ku, Okayama City
TEL
086-252-2211
Homepage URL
tt.toshihisa.tahara@gmail.com
Sponsor or person
Institute
Okayama Saiseikai General Hospital
Institute
Department
Personal name
Funding Source
Organization
Okayama Saiseikai General Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama Saiseikai General Hospital
Address
2-25 Kokutai-cho, Kita-ku, Okayama City
Tel
086-252-2211
tt.toshihisa.tahara@gmail.com
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 | 08 | Month | 30 | 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
27
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
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 09 | 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
Patients who underwent partial/ lobectomy of the liver between October 1, 2019 and May 31, 2021.
measurement item
The 24-hour insulin amount calculated from the insulin infusion rate at the time of withdrawal from the artificial pancreas, and the 24-hour insulin amount calculated from the insulin amount used in the artificial pancreas from the operation to the next morning , preoperative basal insulin level, fasting CPR, HbA1c, body weight, and lactic acid level
Management information
Registered date
| 2022 | Year | 08 | Month | 29 | Day |
Last modified on
| 2022 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053918
| 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 |
