UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018113 |
|---|---|
| Receipt number | R000020969 |
| Scientific Title | The pancreas internal secretion, external secretion and change of the glucose metabolism index after the pancreas operation |
| Date of disclosure of the study information | 2015/08/01 |
| Last modified on | 2021/07/01 12:19:09 |
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Basic information
Public title
The pancreas internal secretion, external secretion and change of the glucose metabolism index after the pancreas operation
Acronym
The pancreas internal secretion, external secretion and change of the glucose metabolism index after the pancreas operation
Scientific Title
The pancreas internal secretion, external secretion and change of the glucose metabolism index after the pancreas operation
Scientific Title:Acronym
The pancreas internal secretion, external secretion and change of the glucose metabolism index after the pancreas operation
Region
| Japan |
Condition
Condition
Patients who have pancreas disease that an operation needs
Classification by specialty
| Endocrinology and Metabolism | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study clarifies the influence of the pancreas operation in the internal secretion, the external secretion, and the postoperative obstacle
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
new diabetes onset or diabetes aggravation
Key secondary outcomes
1)75g oral glucose tolerance test(OGTT):plasma glucose,IRI,CPR
2)Glucagon test(CPR)
3)Pancreatic function diagnostic test (PFD):PABA excretion rate
4)Diabetes metabolism index: HbA1c,glycoalbumin,1.5-AG,plasma glucose
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. The patients who have agreed to participate in this study with an informed consent.
2.Age more than 20
3.Patients who not have the malignant tumor which progressed other than a pancreas disease
Key exclusion criteria
1. Patients judged not to be eligible by the principal investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Ikegami |
Organization
Kindai University School of Medicine
Division name
Department of Endocrinology, Metabolism, and Diabetes
Zip code
5898511
Address
377-2 Ohno-Higashi, Osaka-sayama, Osaka, Japan
TEL
+81-72-366-0221(ext.3125)
ikegami@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihisa |
| Middle name | |
| Last name | Hiromine |
Organization
Kindai University School of Medicine
Division name
Department of Endocrinology, Metabolism, and Diabetes
Zip code
5898511
Address
377-2 Ohno-Higashi, Osaka-sayama, Osaka, Japan
TEL
+81-72-366-0221(ext.3125)
Homepage URL
hiromine@med.kindai.ac.jp
Sponsor or person
Institute
Department of Endocrinology, Metabolism, and Diabetes
Kindai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Health, Labour, and Welfare of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the institutional ethics committee of Kindai University Faculty of Medicine
Address
377-2 Ohno-Higashi, Osaka-sayama, Osaka, Japan
Tel
+81-72-366-0221
gakumu@med.kindai.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
近畿大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational(prospective study)
Management information
Registered date
| 2015 | Year | 06 | Month | 27 | Day |
Last modified on
| 2021 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020969
| 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 |
