UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033585
Receipt number 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 11:21:09

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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 or person

Institute

Jinnouchi hospital

Institute

Department

Personal name



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

Value
https://center6.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