UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055737 |
|---|---|
| Receipt number | R000053690 |
| Scientific Title | Prospective study of glucagon and incretin secretion in patients with diabetes |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2025/04/04 14:39:45 |
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Basic information
Public title
Prospective study of glucagon and incretin secretion in patients with diabetes
Acronym
Prospective study of glucagon and incretin secretion in patients with diabetes
Scientific Title
Prospective study of glucagon and incretin secretion in patients with diabetes
Scientific Title:Acronym
Prospective study of glucagon and incretin secretion in patients with diabetes
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate glucagon and incretin secretion in diabetic patients and clarify the relationship with disease type and duration.
Basic objectives2
Others
Basic objectives -Others
In previous studies, it has been reported that arginine stimulation promotes glucagon secretion and GLP-1 secretion. In a small number of cases, it has been reported that patients with fulminant type 1 diabetes mellitus have decreased glucagon secretion capacity by arginine stimulation test, but this was measured by RIA method, which is less specific than the recently developed sandwich ELISA method, and it is questionable whether the glucagon secretion capacity was correctly evaluated. Based on this, it is possible that glucagon has not been properly evaluated in previous studies. In this study, we will conduct arginine stimulation tests in diabetic patients with various types and durations of diabetes using a new highly specific glucagon measurement system that is available at our hospital, analyze differences in glucagon and incretin secretion, and clarify the characteristics of abnormal glucose metabolism.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Increment of glucagon and GLP-1 secretion by arginine stimulation test
Key secondary outcomes
Correlation between increment of glucagon or GLP-1 and HbA1c, age, gender, clinical indices such as diabetes mellitus type, disease duration, blood pressure, and laboratory tests (blood count, blood glucose, Cre, BUN, uric acid, AST, ALT, ALP, gamma-GTP, LDH, CK, TP, Alb, T-Cho, LDL-C, HDL-C, TG, Amy, Lipa, T-Bil, Na, K, Cl, Ca, urine qualitative, urine sediment, urine protein, urine Alb /Cre as examined at the examination)
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
| Other |
Interventions/Control_1
Arginine 30 g IV over 30 minutes and measure blood glucose, insulin, C-peptide, glucagon, GLP-1, and GIP before loading, 10, 20, 30, 40, 50, 60, 90, and 120 minutes.
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Type 1, type 2, or other type of diabetes patients (including pancreatic diabetes) between 18 and 90 years of age and those with normal glucose tolerance who are attending our hospital.
1-A) Normal glucose tolerance is defined as a fasting blood glucose of less than 110 mg/dl or HbA1c of less than 6.2% at a checkup within the past year.
(2) Those whose attending physician has determined that they can tolerate an arginine stimulation test.
(3) Hemoglobin (Hb) levels of at least 11.3 g/dL.
Key exclusion criteria
(1) Persons strongly suspected of suffering from dementia or psychiatric disorders
(2) Those who are using drugs that affect glucagon and GLP-1 secretion, such as GLP-1 receptor agonists, SGLT2 inhibitors, and DPP-4 inhibitors.
(3) Persons with severe renal or hepatic dysfunction
(4) Persons with bronchial asthma that is difficult to control
(5) Persons deemed inappropriate for this clinical research by the Principal Investigator or a Research Supervisor.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Hamamoto |
Organization
Kansai Electric Power Medical Research Institute
Division name
Yutaka Seino Distinguished Center for Diabetes Research
Zip code
553-0003
Address
2-1-7 Fukushima-ku, Osaka 553-0003
TEL
0664585821
hamamoto.kitanohosp@gmail.com
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Usui |
Organization
Kansai Electric Power Medical Research Institute
Division name
Yutaka Seino Distinguished Center for Diabetes Research
Zip code
553-0003
Address
2-1-7 Fukushima-ku, Osaka 553-0003
TEL
0664585821
Homepage URL
usui0605@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kansai Medical Net Corporation (Kansai Electric Power Medical Research Institute)
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical Net Corporation (Kansai Electric Power Medical Research Institute)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai electric power hospital
Address
2-1-7 Fukushima-ku, Osaka 553-0003
Tel
0664585821
koga.kazuhiro@c3.kepco.co.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
関西電力病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 01 | 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
80
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2024 | Year | 10 | Month | 03 | Day |
Last modified on
| 2025 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053690
