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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040145
Receipt No. 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

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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
Email 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
Email yuma.h.pt@gmail.com

Sponsor
Institute Hamamatsu University Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045771

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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