UMIN-CTR Clinical Trial

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