UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015973 |
|---|---|
| Receipt number | R000018578 |
| Scientific Title | Evaluation of functional beta cell mass with the use of Glucagon stimulation test |
| Date of disclosure of the study information | 2014/12/20 |
| Last modified on | 2014/12/16 21:51:49 |
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Basic information
Public title
Evaluation of functional beta cell mass with the use of Glucagon stimulation test
Acronym
Evaluation of beta cell mass with the use of Glucagon stimulation test
Scientific Title
Evaluation of functional beta cell mass with the use of Glucagon stimulation test
Scientific Title:Acronym
Evaluation of beta cell mass with the use of Glucagon stimulation test
Region
| Japan |
Condition
Condition
Impaired glucose tolerance and Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationships between indices obtained glucagon test and the beta cell mass in type 2 diabetic patients.
Basic objectives2
Others
Basic objectives -Others
To investigate which indices is more sensitive for selection of therapy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
the relationships between indices obtained glucagon test and the beta cell mass
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Impaired glucose tolerance or type 2 diabetic patients who admitted to Iwaki Kyouritsu General Hospital for glycemic control and underwent glucagon test for evaluation of pancreatic beta cell between October, 2011 and December, 2013
Key exclusion criteria
1)GAD antibody positive patient
2)Patients with severe hepatic and renal disease (eGFR less than 45ml/min/1.73m2 (male) or 35 ml/min./1.73 m2 (female) )
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Usui |
Organization
Iwaki Kyoritsu General Hospital
Division name
Division of Endocrinology and Diabetes
Zip code
Address
16 Kusehara, Mimaya-machi, Uchigo, Iwaki, Fukushima
TEL
0246-26-3151
masausui@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Usui |
Organization
Iwaki Kyoritsu General Hospital
Division name
Division of Endocrinology and Diabetes
Zip code
Address
16 Kusehara, Mimaya-machi, Uchigo, Iwaki, Fukushima
TEL
0246-26-3151
Homepage URL
masausui@med.tohoku.ac.jp
Sponsor or person
Institute
Division of Endocrinology and Diabetes, Iwaki Kyoritsu General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2014 | Year | 12 | Month | 20 | 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
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) Indices obtained from glucagon test
2) Relationship between these indices
3) Which indices useful for therapy choice
Management information
Registered date
| 2014 | Year | 12 | Month | 16 | Day |
Last modified on
| 2014 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018578
