UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040419 |
|---|---|
| Receipt number | 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 | 2022/05/18 09:43:28 |
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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
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
maruyama@artsci.kyushu-u.ac.jp
Sponsor or person
Institute
Counseling and Health Support Center,
Kyushu University
Institute
Department
Personal name
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
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
DOI: 10.1678/rheology.50.1
Publication of results
Partially published
Result
URL related to results and publications
DOI: 10.1678/rheology.50.1
Number of participants that the trial has enrolled
20
Results
After obtaining consent, peripheral venous blood was sampled in 20 diabetic patients, and hence the evaluation of the red blood cell deformability was under investigation.
Results date posted
| 2021 | Year | 05 | Month | 17 | Day |
Results Delayed
Results Delay Reason
There was no delay in the process of the
current research.
Date of the first journal publication of results
| 2022 | Year | 02 | Month | 28 | Day |
Baseline Characteristics
Baseline characteristics of the enrolled
outpatients were the same as that in the
initial study design.
Participant flow
Venous blood sampling from antecubital vein
in these enrolled subjects.
Adverse events
There was no adverse events in this study
protocol.
Outcome measures
Circulating red cell deformability in these
subjects that was evaluated by the two-step
filtration technique.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2022 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046078
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/02/01 | keikakusho201904.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2022/02/01 | SP3 IRB審査用 sapoin2020_03_18疾患別.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2022/02/01 | RCF結果報告 2019-0918 SP2-097 作図.xlsx |
