UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051413 |
|---|---|
| Receipt number | R000058647 |
| Scientific Title | Evaluation of the usefulness of new functional tests using insulin and glucagon |
| Date of disclosure of the study information | 2023/06/23 |
| Last modified on | 2023/06/22 11:01:30 |
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Basic information
Public title
Evaluation of the usefulness of new functional tests using insulin and glucagon
Acronym
Evaluation of the usefulness of new functional tests using insulin and glucagon
Scientific Title
Evaluation of the usefulness of new functional tests using insulin and glucagon
Scientific Title:Acronym
Evaluation of the usefulness of new functional tests using insulin and glucagon
Region
| Japan |
Condition
Condition
endocrine and metabolic disorder
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the characteristics of insulin and glucagon responses using tolerance tests in patients with diabetes, insulinoma, and reactive hypoglycemia.
Basic objectives2
Others
Basic objectives -Others
Consider the basis for tailor-made diabetes treatment to select the optimal treatment for each pancreatic beta cell second messenger
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association of arginine loading test and rapid calcium loading test results with changes in HbA1c levels
Glucose, insulin, and glucagon responses after calcium injection (0,3,6,10 min) and arginine injection (0,30,60,90,120 min).
Key secondary outcomes
1. Changes in blood pressure and pulse rate
2. Changes in blood glucose and insulin sensitivity (FPG, GA, IRI, HOMA-R, QUICKI, CPI)
3. Changes in lipids (total cholesterol, HDL cholesterol, triglycerides)
4. Changes in renal function and electrolytes (BUN, Cre, Na, K, Cl, urinary Cr, urinary albumin)
5. Bone effects (ALP, Ca, iP) and changes
6. Evaluation of safety and adverse events (Ht, Na, BUN, glycemic status, adverse events associated with drug administration)
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
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. When an arginine tolerance test is required due to suspected adult growth hormone deficiency or a peripheral rapid calcium tolerance test is required due to suspected insulinoma or medullary thyroid carcinoma in the usual course of medical care.
2. Diagnosis of glucose intolerance, diabetes mellitus, reactive hypoglycemia, insulinoma, or glucagonoma by functional and imaging tests at the hospital, the Department 4. Patients must have maintained the function of major organs (listed below) on the clinical examination within 30 days prior to enrollment.
5. Patients who have given a full explanation of their participation in this study, and who have given written consent of their own free will based on sufficient understanding.
Key exclusion criteria
1) Within 2 months of last use of somatostatin receptor analogs.
2) In case of severe infection, before or after surgery, or serious trauma.
3) Other cases in which the principal investigator or subinvestigator determines that the subject is inappropriate for this study.
4) When arginine tolerance test and rapid peripheral calcium tolerance test are not necessary under normal medical practice.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Toshinari |
| Middle name | |
| Last name | Takamura |
Organization
Kanazawa University Graduate School of Medical sciences
Division name
Department of Endocrinology and metabolism
Zip code
920-8641
Address
13-1 Takara-machi Kanazawa Ishikawa
TEL
076-265-2711
ttakamura@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | Yumie |
| Middle name | |
| Last name | Takeshita |
Organization
Kanazawa university hospital
Division name
Department of Endocrinology and metabolism
Zip code
9208641
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
076-265-2711
Homepage URL
takeshita@m-kanazawa.jp
Sponsor or person
Institute
Kanazawa university hospital
Department of Endocrinology and metabolism
Institute
Department
Personal name
Funding Source
Organization
None
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
kanazawa university
Address
13-1 Takara-machi
Tel
076-265-2110
rinri@adm.kanazawa-u.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
金沢大学附属病院 内分泌・代謝内科
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2023 | Year | 06 | Month | 22 | Day |
Last modified on
| 2023 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058647
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| Registered date | File name |
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