UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056109 |
|---|---|
| Receipt number | R000064112 |
| Scientific Title | An exploratory clinical trial to elucidate the mechanism of glucose metabolism regulation using graduated hyperglycemic clamp method in non-diabetic subjects |
| Date of disclosure of the study information | 2024/11/08 |
| Last modified on | 2024/11/08 22:51:32 |
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Basic information
Public title
An exploratory clinical trial to elucidate the mechanism of glucose metabolism regulation using graduated hyperglycemic clamp method in non-diabetic subjects
Acronym
An exploratory clinical trial using the graduated hyperglycemic clamp method
Scientific Title
An exploratory clinical trial to elucidate the mechanism of glucose metabolism regulation using graduated hyperglycemic clamp method in non-diabetic subjects
Scientific Title:Acronym
An exploratory clinical trial to elucidate the mechanism of glucose metabolism regulation using graduated hyperglycemic clamp method
Region
| Japan |
Condition
Condition
Non-diabetes
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study a new mathematical model incorporating the flow of glucose effectiveness (insulin-independent glucose uptake) and to examine the validity of the new model
Basic objectives2
Others
Basic objectives -Others
Relevance of insulin action on elevated blood glucose
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Examination of fitting of a novel mathematical model incorporating glucose effectiveness
Key secondary outcomes
Relevance of insulin action on elevated blood glucose
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
| Medicine |
Interventions/Control_1
Performing a glucose clamp test on non-diabetic individuals
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) not diagnosed with diabetes
(2) be at least 20 years of age at the time of informed consent
(3) have been fully informed of the purpose of participation in this study, and have given written consent of their own free will based on a thorough understanding of the purpose of the study
Key exclusion criteria
(1) The individuals who are taking drugs that affect glucose metabolism (steroids, immunosuppressants, beta-blockers)
(2) pregnant or possibly pregnant
(3) The individuals who are breast-feeding
(4) The individuals have a known history of hypersensitivity to the test drug or the ingredients in the test
(5) The individuals who have received a cardiac function classification of 3 or 4 by NYHA within the last 1 year
(6) The individuals who have been diagnosed with severe renal dysfunction (eGFR 30 mL/min/1.73 m2 or less) within the last 1 year
(7) Persons with blood clotting abnormalities
(8) The individuals who have been diagnosed with thyroid function abnormalities or electrolyte within the last 1 year
(9) In addition, when the principal investigator deems the patient to be inappropriate as a subject
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Sakaguchi |
Organization
Kobe university
Division name
Department of Diabetes and Endocrinology
Zip code
650-0017
Address
7-5-2, Kusunoki-Cho, Chuo-ku, Kobe
TEL
078-382-5861
kzhkskgc@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Sakaguchi |
Organization
Kobe university
Division name
Department of Diabetes and Endocrinology
Zip code
650-0017
Address
7-5-2, Kusunoki-Cho, Chuo-ku, Kobe
TEL
078-382-5861
Homepage URL
kzhkskgc@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe university
Institute
Department
Personal name
Funding Source
Organization
Others
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
Intervention research ethics revies committee
Address
7-5-2, Kusunoki-Cho, Chuo-ku, Kobe
Tel
0783826669
kainyu@med.kobe-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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 11 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | 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 | 11 | Month | 08 | Day |
Last modified on
| 2024 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064112
