UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002359 |
|---|---|
| Receipt number | R000002897 |
| Scientific Title | A study of insulin secretion and insulin resistance using with glucose clamp techinique |
| Date of disclosure of the study information | 2009/09/15 |
| Last modified on | 2017/03/05 22:58:29 |
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Basic information
Public title
A study of insulin secretion and insulin resistance using with glucose clamp techinique
Acronym
A study of insulin secretion and insulin resistance using with glucose clamp techinique
Scientific Title
A study of insulin secretion and insulin resistance using with glucose clamp techinique
Scientific Title:Acronym
A study of insulin secretion and insulin resistance using with glucose clamp techinique
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Precise evaluation of insulin secretion and insulin resistance in Japanese type 2 DM using with glucose clamp technique
Basic objectives2
Others
Basic objectives -Others
To clarify natural history of type 2 DM in Japanese
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
insulin secretion: first and second phase insulin secretion under hyperglycemic clamp
insulin resitance: glucose infusion rate under hyperinsulinemic clamp
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Capable to be inserted cathter at three different site at both arm
Key exclusion criteria
Having insulin allergy or insulin antibody
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Sakaguchi |
Organization
Department of internal medicine, Kobe University Graduate School of medicine
Division name
Division of Diabetes, Netabolism and Endocrinology
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
078-382-5861
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Sakaguchi |
Organization
Department of internal medicine, Kobe University Graduate School of medicine
Division name
Division of Diabetes, Netabolism and Endocrinology
Zip code
Address
TEL
Homepage URL
kzhkskgc@med.kobe-u.ac.jp
Sponsor or person
Institute
Divison of Diabetes, metabolism and Endcrinology
Department of Internal Medicine,
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
entrasted accounting money
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 09 | Month | 15 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Using with glucose clamp technique, insulin secretion capacity and insulin resistance should be measured precisely in 50 Type 2 DMs, 20 IGTs and 20 healthy volunteers
Management information
Registered date
| 2009 | Year | 08 | Month | 20 | Day |
Last modified on
| 2017 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002897
| 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 |
