UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012090
Receipt number R000014127
Scientific Title identification of plasma protein beneficial for diagnosis of diabetes mellitus
Date of disclosure of the study information 2013/10/21
Last modified on 2015/04/21 19:07:22

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Basic information

Public title

identification of plasma protein beneficial for diagnosis of diabetes mellitus

Acronym

identification of plasma protein beneficial for diagnosis of diabetes mellitus

Scientific Title

identification of plasma protein beneficial for diagnosis of diabetes mellitus

Scientific Title:Acronym

identification of plasma protein beneficial for diagnosis of diabetes mellitus

Region

Japan


Condition

Condition

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

we aim to identify plasma protein useful for diagnosis of diabetes mellitus.

Basic objectives2

Others

Basic objectives -Others

we aim to identify plasma secreted protein that indicates glycemic pattern on 75g OGTT.

Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

We compare plasma candiaite protein levels with glycemic pattern of 75g OGTT.

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

20 years-old <=

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

patients that suspected Diabetes mellitus

Key exclusion criteria

none

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Katsumi Iizuka

Organization

Gifu University Hospital

Division name

Department of Diabetes and Endocrinology

Zip code


Address

1-1, yanagido, gifu

TEL

058-230-6377

Email

kiizuka@gifu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Katsumi Iizuka

Organization

Gifu University hospital

Division name

Department of diabetes and endocrinology

Zip code


Address

1-1 yanagido, Gifu

TEL

058-230-6377

Homepage URL


Email

kiizuka@gifu-u.ac.jp


Sponsor or person

Institute

gifu university hospital

Institute

Department

Personal name



Funding Source

Organization

gifu university 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



Other administrative information

Date of disclosure of the study information

2013 Year 10 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

2013 Year 02 Month 07 Day

Date of IRB


Anticipated trial start date

2013 Year 02 Month 07 Day

Last follow-up date

2014 Year 11 Month 01 Day

Date of closure to data entry

2014 Year 11 Month 01 Day

Date trial data considered complete

2015 Year 03 Month 01 Day

Date analysis concluded

2015 Year 03 Month 01 Day


Other

Other related information

we compare glycemic pattern in 75g OGTT with plasma protein levels.


Management information

Registered date

2013 Year 10 Month 21 Day

Last modified on

2015 Year 04 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014127


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name