UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011578
Receipt number R000013542
Scientific Title Closs sectional study for the usability of estimated hemoglobin A1c in type 2 diabetes with chronic kidney disease and hemodialysis.
Date of disclosure of the study information 2013/08/27
Last modified on 2014/01/14 10:28:31

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Basic information

Public title

Closs sectional study for the usability of estimated hemoglobin A1c in type 2 diabetes with chronic kidney disease and hemodialysis.

Acronym

Study for the usability of estimated hemoglobin A1c in type 2 diabetes.

Scientific Title

Closs sectional study for the usability of estimated hemoglobin A1c in type 2 diabetes with chronic kidney disease and hemodialysis.

Scientific Title:Acronym

Study for the usability of estimated hemoglobin A1c in type 2 diabetes.

Region

Japan


Condition

Condition

Type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to investigate the usability of estimated hemoglobin A1c (eHbA1c) comparison with hemoglobin A1c and glycoalbumin in type 2 diabetes with chronic kidney disease and hemodialysis therapy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

eHbA1c, plasma glucose, HbA1c, GA.

Key secondary outcomes

eGFR, BMI, hemoglobin, albumin, urinaly protein concentration and medications.


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


Not applicable

Gender

Male and Female

Key inclusion criteria

Outpatients of type 2 diabetes with chronic kidney disease and hemodialysis therapy.

Key exclusion criteria

Those who are less than 20 years old.
Those who are suffer from severe disease other than type 2 diabetes and chronic kidney disease.

Target sample size

500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akihiko Nakamura

Organization

Osafune clinic

Division name

Internal medicine

Zip code


Address

332-1, Haji, Osafune-cho, Okayama, Japan

TEL

0869-26-8080

Email

osafune-clinic@nifty.com


Public contact

Name of contact person

1st name
Middle name
Last name Akihiko Nakamura

Organization

Osafune clinic

Division name

Internal medicine

Zip code


Address

332-1, Haji, Osafune-cho, Okayama, Japan

TEL

0869-26-8080

Homepage URL


Email

osafune-clinic@nifty.com


Sponsor or person

Institute

Osafune clinic

Institute

Department

Personal name



Funding Source

Organization

Center for Innovative Clinical Medicine, Okayama University Hospital

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Innoshima general hospital,
Center for Innovative Clinical Medicine, Okayama University Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

YES

Study ID_1

No10

Org. issuing International ID_1

Innoshima general hospital

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

おさふねクリニック(岡山県)


Other administrative information

Date of disclosure of the study information

2013 Year 08 Month 27 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

2013 Year 08 Month 26 Day

Date of IRB


Anticipated trial start date

2013 Year 08 Month 27 Day

Last follow-up date

2013 Year 10 Month 31 Day

Date of closure to data entry

2013 Year 10 Month 31 Day

Date trial data considered complete

2013 Year 10 Month 31 Day

Date analysis concluded

2013 Year 11 Month 30 Day


Other

Other related information

Cross-sectional study, random sampling.


Management information

Registered date

2013 Year 08 Month 26 Day

Last modified on

2014 Year 01 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013542


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name