UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009649 |
|---|---|
| Receipt number | R000011322 |
| Scientific Title | Observational study about the relationships between pancreatic beta cell function and glycemic control and the treatment in Japanese patients with type 2 diabetes |
| Date of disclosure of the study information | 2013/01/07 |
| Last modified on | 2013/12/27 09:42:11 |
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Basic information
Public title
Observational study about the relationships between pancreatic beta cell function and glycemic control and the treatment in Japanese patients with type 2 diabetes
Acronym
Observational study about the relationships between pancreatic beta cell function and glycemic control
Scientific Title
Observational study about the relationships between pancreatic beta cell function and glycemic control and the treatment in Japanese patients with type 2 diabetes
Scientific Title:Acronym
Observational study about the relationships between pancreatic beta cell function and glycemic control
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationships between beta cell function evaluated by glucagon test and the long term glycemic control and the treatment in type 2 diabetic patients
Basic objectives2
Others
Basic objectives -Others
To investigate the usefulness of glucagon test
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
the change of HbA1c from the baseline
Key secondary outcomes
the course of the treatments
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetic patients who admitted to Juntendo University Hospital for glycemic control and underwent glucagon test for evaluation of pancreatic beta cell
Key exclusion criteria
1)Patients with severe hepatic and renal disease (serum creatinine: more than 1.5mg/dl and hemodialysis)
2)Type 1 diabetes
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Kanazawa |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Metabolism & Endocrinology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Metabolism & Endocrinology
Zip code
Address
TEL
03-3813-3111
Homepage URL
Sponsor or person
Institute
Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine
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
| 2013 | Year | 01 | Month | 07 | 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
| 2012 | Year | 04 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | 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
Prospective and observational study
Management information
Registered date
| 2012 | Year | 12 | Month | 27 | Day |
Last modified on
| 2013 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011322
