UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040145 |
|---|---|
| Receipt number | R000045771 |
| Scientific Title | Effects of microvascular blood flow on Skeletal muscle easy fatigue state in diabetic kidney disease patients |
| Date of disclosure of the study information | 2020/04/30 |
| Last modified on | 2020/04/13 17:28:03 |
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Basic information
Public title
Causes of muscle fatigue in Diabetic kidney disease patients
Acronym
Muscle fatigue test in diabetic kidney disease patients
Scientific Title
Effects of microvascular blood flow on Skeletal muscle easy fatigue state in diabetic kidney disease patients
Scientific Title:Acronym
Muscle fatigue test in diabetic kidney disease patients
Region
| Japan |
Condition
Condition
Diabetic kidney disease
Classification by specialty
| Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of microvascular blood flow on muscle fatigue in diabetic kidney disease patients
Basic objectives2
Others
Basic objectives -Others
Correlation,Impact
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
muscle fatigue,microvascular blood flow
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Performing a dynamic fatigue task while measuring microvascular blood flow in diabetic kidney disease patients
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Person who is admitted to our hospital or consults outpatient
Patients who agreed to participate in the study
Patients who have independent walking
Key exclusion criteria
Pregnant woman
Patients with comorbidity and history of severe heart or lung disease
Patients with albuminuria less than 30mg/gCr and e-GFR90 or more
Dementia patients
Uncured cancer patients
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Tsuriya |
Organization
Hamamatsu University Hospital
Division name
Medical University Hospital Second Internal Medicine Department
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL
053-435-2704
dtsuri@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuma |
| Middle name | |
| Last name | Hirano |
Organization
Hamamatsu University Hospital
Division name
Department of Rehabilitation
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL
053-435-2111
Homepage URL
yuma.h.pt@gmail.com
Sponsor or person
Institute
Hamamatsu University Hospital
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
International University of Health and Welfare
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Hamamatsu University School of Medicine(EC HUSM)
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
Tel
053-435-2680
rinri@hama-med.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
浜松医科大学医学部附属病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 30 | 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
| 2020 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 13 | Day |
Last modified on
| 2020 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045771
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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