UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012913
Receipt number R000012752
Scientific Title Investigation of popular diabetes-asscociated indices: according to the class of glucose tolerance
Date of disclosure of the study information 2014/01/21
Last modified on 2016/01/21 13:24:52

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Basic information

Public title

Investigation of popular diabetes-asscociated indices: according to the class of glucose tolerance

Acronym

KOBE Indices-One Study

Scientific Title

Investigation of popular diabetes-asscociated indices: according to the class of glucose tolerance

Scientific Title:Acronym

KOBE Indices-One Study

Region

Japan


Condition

Condition

type 2 diabetes

Classification by specialty

Medicine in general Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigation of the relationship among popular diabetes associated indices and clamp derived indices

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

relationship among popular indices and precise indices

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

21 years-old <=

Age-upper limit

71 years-old >

Gender

Male and Female

Key inclusion criteria

Persons who took both 75g OGTT and Clamp examination
FPG less than 130 mg/dl

Key exclusion criteria

Type 1 diabetes (including SPIDDM)
Other specific type diabetes
NPH or long acting insulin user

Target sample size

103


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhiko Sakaguchi

Organization

Kobe University School of medicine

Division name

Diabetes and Endocrinology

Zip code


Address

7-5-1Kusunoki-Cho, Chuo-Ku, Kobe

TEL

078-382-5861

Email

kzhkskgc@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazuhiko Sakaguchi

Organization

Kobe University School of Medicine

Division name

Diabetes and Endocrinology

Zip code


Address

7-5-11Kusunoki-Cho, Chuo-Ku, Kobe

TEL

078-382-5861

Homepage URL


Email

kzhkskgc@med.kobe-u.ac.jp


Sponsor or person

Institute

Diabetes and Endocrinology, Kobe university school of medicine

Institute

Department

Personal name



Funding Source

Organization

none

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

2014 Year 01 Month 21 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

Enrolling by invitation

Date of protocol fixation

2014 Year 01 Month 21 Day

Date of IRB


Anticipated trial start date

2014 Year 01 Month 21 Day

Last follow-up date


Date of closure to data entry

2015 Year 12 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2014 Year 01 Month 21 Day

Last modified on

2016 Year 01 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012752


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name