UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020958 |
|---|---|
| Receipt number | R000024182 |
| Scientific Title | Development of hyperglycemic glucose clamp methods and evaluation of its outcomes in healthy subjects |
| Date of disclosure of the study information | 2016/02/12 |
| Last modified on | 2017/01/26 16:29:31 |
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Basic information
Public title
Development of hyperglycemic glucose clamp methods and evaluation of its outcomes in healthy subjects
Acronym
Development of hyperglycemic glucose clamp methods and evaluation of its outcomes in healthy subjects
Scientific Title
Development of hyperglycemic glucose clamp methods and evaluation of its outcomes in healthy subjects
Scientific Title:Acronym
Development of hyperglycemic glucose clamp methods and evaluation of its outcomes in healthy subjects
Region
| Japan |
Condition
Condition
Diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop the series of methods to safely maintain hyperglycemic plateau, and to evaluate its outcomes, when hyperglycemic clamp technique is used in healthy male subjects.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of hyperglycemic glucose clamp technique.
Evaluation of the parameters of the first- and second- insulin secretory ability, and the transitions of glucose, insulin and c-peptide
Key secondary outcomes
Safety by evaluating AEs, serum potassium, and VAS for pain.
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
| Maneuver |
Interventions/Control_1
Hyperglycemic glucose clamp technique.
120 minute clamp/ subject
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
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
1, Healthy Japanese male subjects who provide signed written informed consent.
2, Subjects between 20 and 40 (inclusive) year of age at the time of consent.
3, Subjects with BMI <=18.5 and >25.0 at the time of screening.
4, Subjects with negative serological tests.
5, Subject judged as adequate for this study by study physician at screening.
Key exclusion criteria
1, Subjects with present and/or past illness considered inadequate for this study.
2, Subjects with past history of drug allergy.
3, Subjects with history of caffeine, alcohol and/or drug abuse.
4, Subjects who was judged not appropriate for this study by study physician.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanari Shiramoto |
Organization
SOUSEIKAI Hakata Clinic
Division name
Clinical Pharmacology Department
Zip code
Address
Random Square (5th-7th floors) 6-18 Tenyamachi, Hakata-ku, Fukuoka, 812-0025
TEL
0922837701
masanari-shiramoto@lta-med.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hinako Uchimaru |
Organization
SOUSEIKAI Hakata Clinic
Division name
Planning & Coordination Dept
Zip code
Address
Random Square (5th-7th floors) 6-18 Tenyamachi, Hakata-ku, Fukuoka, 812-0025
TEL
0922837701
Homepage URL
hinako-uchimaru@lta-med.com
Sponsor or person
Institute
SOUSEIKAI Hakata Clinic
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
Address
Tel
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
医療法人相生会 博多クリニック（福岡県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 12 | 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
Hyperglycemic state was maintained in all six subjects.
Results of insulin and C-peptide indicated effectiveness of our methods to evaluate the first- and second- insulin secretory ability quantitatively.
No AE including clinically significant decrease of Potassium was observed, and our methods were considered technically safe.
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
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 09 | Day |
Last modified on
| 2017 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024182
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
