UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024978 |
|---|---|
| Receipt number | R000028743 |
| Scientific Title | Prognostic factor concerned with glucose tolerance change after pancreatectomy. |
| Date of disclosure of the study information | 2016/11/24 |
| Last modified on | 2023/05/31 09:22:29 |
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Basic information
Public title
Prognostic factor concerned with glucose tolerance change after pancreatectomy.
Acronym
Prognostic factor concerned with glucose tolerance change after pancreatectomy.
Scientific Title
Prognostic factor concerned with glucose tolerance change after pancreatectomy.
Scientific Title:Acronym
Prognostic factor concerned with glucose tolerance change after pancreatectomy.
Region
| Japan |
Condition
Condition
pancreatic cancer, diabetes
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigate glucose tolerance changes after pancreatectomy in patients whose pre-operative glucose intolerance are normal or impaired (IGT).
Basic objectives2
Others
Basic objectives -Others
Elucidate risk factors of diabetes after pancreatectomy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
glucose tolerance change after pancreatectomy
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who undergo a pancreatectomy operation for any pancreatic disease in our hospital.
2.Patients without chemotherapy and radiation therapy for pancreatic disease.
Key exclusion criteria
1.Diabetes
2.Non-curative operation
3.Recurrence or death after surgery
4.Chronic pancreatitis
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Wada |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558 Japan
TEL
086-235-7235
junwada@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Takahashi |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558 Japan
TEL
086-235-7235
Homepage URL
hirokotakahashi@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
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
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558 Japan
Tel
086-235-6503
mae6605@adm.okayama-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
| 2016 | Year | 11 | Month | 24 | Day |
Related information
URL releasing protocol
not released
Publication of results
Unpublished
Result
URL related to results and publications
not released
Number of participants that the trial has enrolled
47
Results
Glucose intolerance did not change.
Results date posted
| 2022 | Year | 11 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who had pancreatectomy
Participant flow
Patients had regular blood test and HbA1c level was checked.
Adverse events
Non
Outcome measures
HbA1c
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 24 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observational study
Management information
Registered date
| 2016 | Year | 11 | Month | 24 | Day |
Last modified on
| 2023 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028743
| 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 |
