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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040419
Receipt No. R000046078
Scientific Title Disease-specific observational study of red cell deformability using two-step filtration method
Date of disclosure of the study information 2020/07/01
Last modified on 2020/05/16

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Basic information
Public title Red cell flexibility study using two-step filtration
Acronym Red cell flexibility study
Scientific Title Disease-specific observational study of red cell deformability using two-step filtration method
Scientific Title:Acronym Observational study of red cell deformability using two-step filtration method
Region
Japan

Condition
Condition Diabetes mellitus
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Assessment of the red cell deformability in diabetic patients.
Basic objectives2 Others
Basic objectives -Others Correlation between the red cell deformability and the diabetic complications.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Investigation of impairment of the red cell deformability in diabetic patients.
Key secondary outcomes Correlation between the red cell deformability and the diabetic complications, and the rheological validity assessment of the two-step filtration method.

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
90 years-old >
Gender Male and Female
Key inclusion criteria 1. diabetic patients
2. patients who can agree with the proposal of enrollment.
3. patients aged 20 years old or more.
Key exclusion criteria 1. paients with anemia (Hb < 8 g/dl)
2. patents showing poor general condition (performance status score > 3points)
3. paients with diabetes under unstable control condition including coma or hypoglycemia
4. patients judged inappropriate to enroll into the study.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Toru
Middle name
Last name Maruyama
Organization Kyushu University
Division name Counseling and Health Support Center
Zip code 819-0395
Address Fukuoka, Nishi-ku 744
TEL 092-802-5113
Email maruyama@artsci.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Toru
Middle name
Last name Maruyama
Organization Kyushu Univerdity
Division name Counseling and Health Support Center
Zip code 819-0395
Address Nishi-ku
TEL +81925837863
Homepage URL
Email maruyama@artsci.kyushu-u.ac.jp

Sponsor
Institute Counseling and Health Support Center,
Kyushu University
Institute
Department

Funding Source
Organization BOOCS Clinic,
Ten-ya-cho 16-18
Random Square 6F
Fukuoka, Hakata-ku,
812-0025, Japan
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization JP

Other related organizations
Co-sponsor Institute of Rheological Function of Foods,
Co.Ltd
Name of secondary funder(s) non

IRB Contact (For public release)
Organization Center for Clinical and Translational Research
Address Maidashi 3-1-1, Higashi-ku, Fukuoka, Japan
Tel 092-642-5082
Email byshinsa@jimu.kyushu-u.ac.jp

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 九州大学病院

Other administrative information
Date of disclosure of the study information
2020 Year 07 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 Preinitiation
Date of protocol fixation
2020 Year 04 Month 01 Day
Date of IRB
2020 Year 06 Month 01 Day
Anticipated trial start date
2020 Year 07 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
2021 Year 01 Month 31 Day
Date trial data considered complete
2021 Year 02 Month 28 Day
Date analysis concluded
2021 Year 05 Month 31 Day

Other
Other related information This protocol is based on the domestic joint research project including the Kyushu University.

Management information
Registered date
2020 Year 05 Month 16 Day
Last modified on
2020 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046078

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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