UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015235 |
|---|---|
| Receipt number | R000017710 |
| Scientific Title | Evaluation of plasma glucagon and incretin hormones measuring reagents |
| Date of disclosure of the study information | 2014/09/24 |
| Last modified on | 2025/10/09 09:45:02 |
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Basic information
Public title
Evaluation of plasma glucagon and incretin hormones measuring reagents
Acronym
A study on plasma glucagon secretion
Scientific Title
Evaluation of plasma glucagon and incretin hormones measuring reagents
Scientific Title:Acronym
A study on plasma glucagon secretion
Region
| Japan |
Condition
Condition
Subjects with normal glucose tolerance
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate plasma glucagon secretion by novel specific enzyme immunoassay for glucagon (1-29) in subjects with normal glucose tolerance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma glucagon levels, Cross-reactivity to oxyntomodulin, et al.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Measurement reagent
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Normal glucose tolerance and no underlying diseases
Key exclusion criteria
Impaired glucose torelance and diabetes mellitus
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Toshihiro |
| Middle name | |
| Last name | Matuo |
Organization
Hyogo College of Medicine
Division name
Division of Diabetes, Endocrinology and Metabolism, Department of Internal Medicine
Zip code
6638501
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo, 663-8501, Japan
TEL
0798-45-6592
matuo@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiki |
| Middle name | |
| Last name | Kusunoki |
Organization
Hyogo College of Medicine
Division name
Division of Diabetes, Endocrinology and Metabolism, Department of Internal Medicine
Zip code
6638501
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo, 663-8501, Japan
TEL
0798-45-6592
Homepage URL
ykusu@hyo-med.ac.jp
Sponsor or person
Institute
Division of Diabetes, Endocrinology and Metabolism, Department of Internal Medicine, Hyogo College 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
Hyogo Collefe of Medicine
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo, 663-8501, Japan
Tel
0798-45-6592
ykusu@hyo-med.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
| 2014 | Year | 09 | Month | 24 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/jdi.12400
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/jdi.12400
Number of participants that the trial has enrolled
42
Results
The development of a new glucagon measurement system has enabled more accurate glucagon measurement than previously possible, yielding valuable insights into the etiology and pathogenesis of diabetes.
Results date posted
| 2025 | Year | 10 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2015 | Year | 07 | Month | 14 | Day |
Baseline Characteristics
Normal glucose tolerance subjects and patients with type 2 diabetes mellitus
Participant flow
Participants underwent a 75g oral glucose tolerance test (OGTT). Blood samples were collected before the OGTT and at 15, 30, 60, and 120 minutes after its initiation to measure plasma glucose, immunoreactive insulin (IRI), and glucagon (1-29). Blood glucose levels were measured using the BioMajesty JCA-BM9000 series (Japan Electro-Optics Laboratory, Tokyo) via the hexokinase UV method. IRI was measured using a chemiluminescent enzyme immunoassay with the Lumipulse Presto II (Fuji Rebio Co., Ltd., Tokyo, Japan). In preparation for glucagon (1-29) measurement, plasma was separated using BD P800 tubes (BD Diagnostics, Franklin Lakes, NJ, USA) containing K2 ethylenediaminetetraacetic acid, protease, esterase, and dipeptidyl peptidase-4 inhibitors. Glucagon (1-29) in the separated plasma was measured using three different glucagon measurement kits according to the manufacturers' recommendations.
Adverse events
None
Outcome measures
Plasma glucose, Inslin, glucagon (1-29), glicentin (1-69), oxyntmodulin, etc.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 24 | Day |
Last modified on
| 2025 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017710
