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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020958
Receipt No. 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

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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
Email 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
Email hinako-uchimaru@lta-med.com

Sponsor
Institute SOUSEIKAI Hakata Clinic
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024182

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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