UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019471 |
|---|---|
| Receipt number | R000022036 |
| Scientific Title | islet transplantation for insulin-dependent diabetes mellitus |
| Date of disclosure of the study information | 2015/11/10 |
| Last modified on | 2024/05/01 19:34:50 |
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Basic information
Public title
islet transplantation for insulin-dependent diabetes mellitus
Acronym
islet transplantation for insulin-dependent diabetes mellitus
Scientific Title
islet transplantation for insulin-dependent diabetes mellitus
Scientific Title:Acronym
islet transplantation for insulin-dependent diabetes mellitus
Region
| Japan |
Condition
Condition
insulin-dependent diabets mellitus
Classification by specialty
| Endocrinology and Metabolism | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to stably control blood sugar
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
HbA1c<7.4% a year after islet transplantation and percentage of recipients without hypoglycemia 90 to 365 days after islet transplantation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
islet allograft transplantation
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
unstable insulin-dependent diabetes mellitus
Key exclusion criteria
1) severe heart and/or liver disease
2) alcoholism
3) infection
4) malignant disease
5) severe obesity (BMI>25kg/m2)
6) retinopathy
7) other severe illness
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Soejima |
Organization
Shinshu University
Division name
School of Medicine, Department of Surgery
Zip code
390-8621
Address
Asahi 3-1-1, Matsumoto, Japan
TEL
0263-37-2654
ysoejima@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsuyoshi |
| Middle name | |
| Last name | Mita |
Organization
Shinshu University
Division name
School of Medicine, Department of Surgery
Zip code
390-8621
Address
Asahi 3-1-1, Matsumoto, Japan
TEL
0263-37-2654
Homepage URL
mita@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Shinshu University
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
Shinshu University, School of Medicine, IRB
Address
Asahi 3-1-1, Matsumoto, Japan
Tel
0263-35-4600
mdrinri@shinshu-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
| 2015 | Year | 11 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2027 | 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
| 2015 | Year | 10 | Month | 23 | Day |
Last modified on
| 2024 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022036
