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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018113
Receipt No. 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 2019/07/01

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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)
Email 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
Email hiromine@med.kindai.ac.jp

Sponsor
Institute Department of Endocrinology, Metabolism, and Diabetes
Kindai University School of Medicine
Institute
Department

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
Email 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
2020 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
2019 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020969

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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