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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010575
Receipt No. 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

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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
Email 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
Email fuki@juntendo.ac.jp

Sponsor
Institute juntendo university
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012247

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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