UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010575 |
|---|---|
| Receipt number | R000012247 |
| Scientific Title | Evaluation of the clinical utility of ultrasensitive C-peptide assay with glucagon stimulation test in Type 1 diabetic patients |
| Date of disclosure of the study information | 2013/04/25 |
| Last modified on | 2020/04/28 16:11:46 |
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Basic information
Public title
Evaluation of the clinical utility of ultrasensitive C-peptide assay with glucagon stimulation test in Type 1 diabetic patients
Acronym
Evaluation of the clinical utility of ultrasensitive C-peptide assay with glucagon stimulation test in Type 1 diabetic patients
Scientific Title
Evaluation of the clinical utility of ultrasensitive C-peptide assay with glucagon stimulation test in Type 1 diabetic patients
Scientific Title:Acronym
Evaluation of the clinical utility of ultrasensitive C-peptide assay with glucagon stimulation test in Type 1 diabetic patients
Region
| Japan |
Condition
Condition
Type 1 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate residual insulin by using ultrasensitive C-peptide of type 1 diabetic patients, with glucagon stimulation test.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Variability of glucose daily profile by using Continuous Glucose Monitoring System and Self Monitoring Blood Glucose
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Ultrasensitive C-peptide
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)subjcets whose age are more than 20 years
(2)no restriction on gender
(3)written informed consent was obtained from all subjects after they had been provided with sufficient information
about the study
Key exclusion criteria
(1)Patients with serious liver or renal insufficiency
(2)Patients with remarkable metabolic disorder
(3)Judged as ineligible by clinical investigators
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Fuki |
| Middle name | |
| Last name | Ikeda |
Organization
Juntendo University Graduate School of Medicine
Division name
Dept. of Metabolism and Endocrinology
Zip code
1138421
Address
2-1-1 Hongo Bunkyo-ku, Tokyo, JAPAN
TEL
0358021579
fuki@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Fuki |
| Middle name | |
| Last name | Ikeda |
Organization
Juntendo University Graduate School of Medicine
Division name
Dept. of Metabolism and Endocrinology
Zip code
1138421
Address
2-1-1 Hongo Bunkyo-ku, Tokyo, JAPAN
TEL
03-3813-3111
Homepage URL
fuki@juntendo.ac.jp
Sponsor or person
Institute
juntendo university
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
Juntendo university
Address
3-1-3 Hongo Bunkyo-ku, Tokyo, JAPAN
Tel
03-5802-1584
kenkyu5858@juntendo.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
| 2013 | Year | 04 | Month | 25 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
5
Results
The number of registered cases was not sufficient.
Analysis of patients who were able to perform the study showed no difference in residual endogenous insulin secretion depending on duration.
Results date posted
| 2020 | Year | 04 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Type 1 diabetes
Participant flow
Tested after obtained Informed Consent when Pt. admitted to hospital
Adverse events
none
Outcome measures
C-peptide
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2013 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2013 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 23 | Day |
Last modified on
| 2020 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012247
| 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 |
