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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032014
Receipt No. R000036534
Scientific Title To examination of factors that affect for blood insulin concentrationat steady state in hyperinsulinemic-euglycemic clamp.
Date of disclosure of the study information 2019/04/01
Last modified on 2018/03/30

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Basic information
Public title To examination of factors that affect for blood insulin concentrationat steady state in hyperinsulinemic-euglycemic clamp.
Acronym To examination of factors that affect for blood insulin concentrationat steady state in hyperinsulinemic-euglycemic clamp.
Scientific Title To examination of factors that affect for blood insulin concentrationat steady state in hyperinsulinemic-euglycemic clamp.
Scientific Title:Acronym To examination of factors that affect for blood insulin concentrationat steady state in hyperinsulinemic-euglycemic clamp.
Region
Japan

Condition
Condition Untreated type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examination of factors that affect for blood insulin concentrationat steady state in hyperinsulinemic-euglycemic clamp.
Basic objectives2 Others
Basic objectives -Others To examination of factors that affect for blood insulin concentrationat steady state in hyperinsulinemic-euglycemic clamp.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The blood insulin concentrationat steady state in hyperinsulinemic-euglycemic clamp
Key secondary outcomes Result of body composition analysis

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 Patient with untreated type 2 diabetes mellitus who underwent a hyperinsulinemic-euglycemic clamp test.
Key exclusion criteria no
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noboru Kurinami
Organization Jinnouchi Hospital
Division name Diabetes Care Center
Zip code
Address 6-2-3, Kuhonji Chuo-ku, Kumamoto-City, Kumamoto Japan
TEL 096-363-0011
Email kurinami@jinnouchi.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noboru Kurinami
Organization Jinnouchi Hospital
Division name Diabetes Care Center
Zip code
Address 6-2-3, Kuhonji Chuo-ku, Kumamoto-City, Kumamoto Japan
TEL 096-363-0011
Homepage URL
Email kurinami@jinnouchi.or.jp

Sponsor
Institute Jinnouchi Hospital
Institute
Department

Funding Source
Organization Jinnouchi Hospital
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 陣内病院(熊本)

Other administrative information
Date of disclosure of the study information
2019 Year 04 Month 01 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 No longer recruiting
Date of protocol fixation
2018 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information All patients with untreated T2DM who underwent a hyperinsulinemic-euglycemic clamp test in the Diabetes Care Center of Jinnouchi Hospital between June 2014 and March 2018.

Management information
Registered date
2018 Year 03 Month 30 Day
Last modified on
2018 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036534

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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