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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011578
Receipt No. 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

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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
Institute Osafune clinic
Institute
Department

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
URL(English) https://upload.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


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