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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002359
Receipt No. 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

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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
Email

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
Email kzhkskgc@med.kobe-u.ac.jp

Sponsor
Institute Divison of Diabetes, metabolism and Endcrinology
Department of Internal Medicine,
Kobe University Graduate School of Medicine
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002897

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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