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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033585
Receipt No. R000038299
Scientific Title Gender specific cut-off values of BMFR for the Insulin resistance in Treatment naive T2DM
Date of disclosure of the study information 2019/01/01
Last modified on 2018/08/01

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Basic information
Public title Gender specific cut-off values of BMFR for the Insulin resistance in Treatment naive T2DM
Acronym Gender specific cut-off values of BMFR for the Insulin resistance
Scientific Title Gender specific cut-off values of BMFR for the Insulin resistance in Treatment naive T2DM
Scientific Title:Acronym Gender specific cut-off values of BMFR for the Insulin resistance
Region
Japan

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

Objectives
Narrative objectives1 Gender specific cut-off values of BMFR for the Impaired Insulin sensitivity in Treatment naive T2DM.
Basic objectives2 Others
Basic objectives -Others We diagnosed the presence of insulin sensitivity disorder by hyperinsulinemic-euglycemic clamp examination, and calculated the body muscle to fat ratio (BMFR)from the body composition analysis result by the bioelectrical impedance method.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes In patients with untreated type 2 diabetes, the presence of insulin sensitivity disorder diagnosed by hyperinsulinemic-euglycemic clamp examination, and the body muscle to fat ratio (BMFR) calculated from the body composition analysis result by the bioelectrical impedance method are compared and examined.
Key secondary outcomes M/I ratio diagnosed by hyperinsulinemic-euglycemic clamp examination.

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
20 years-old <=
Age-upper limit
99 years-old >=
Gender Male and Female
Key inclusion criteria Patients with untreated type 2 diabetes mellitus
Key exclusion criteria Diabetic ketoacidosis, Severe infection, Malignant disease, Examination impossible patient
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noboru Kurinami
Organization jinnouchi Hosptal
Division name Internal medicine
Zip code
Address 6-2-3, Kuhonji, Chuo-ku Kumamoto-shi, Kumamoto, 862-0976, 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 Hosptal
Division name Internal medicine
Zip code
Address 6-2-3, Kuhonji, Chuo-ku Kumamoto-shi, Kumamoto, 862-0976, 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 Other
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(熊本県)

Other administrative information
Date of disclosure of the study information
2019 Year 01 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 Completed
Date of protocol fixation
2018 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
2018 Year 08 Month 01 Day
Date of closure to data entry
2018 Year 08 Month 07 Day
Date trial data considered complete
2018 Year 08 Month 08 Day
Date analysis concluded
2018 Year 08 Month 15 Day

Other
Other related information Design name:
Single facility retrospective observation study

Management information
Registered date
2018 Year 08 Month 01 Day
Last modified on
2018 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038299

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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