UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061161 |
|---|---|
| Receipt number | R000069991 |
| Scientific Title | The Relationship Between FMD and Nutritional Status in Dialysis Patients |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2026/04/04 21:32:27 |
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Basic information
Public title
The Relationship Between FMD and Nutritional Status in Dialysis Patients
Acronym
The Relationship Between FMD and Nutritional Status in Dialysis Patients
Scientific Title
The Relationship Between FMD and Nutritional Status in Dialysis Patients
Scientific Title:Acronym
The Relationship Between FMD and Nutritional Status in Dialysis Patients
Region
| Japan |
Condition
Condition
Dialysis Patients
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Dialysis patients often experience cardiovascular complications, and poor nutritional status and frailty are significant concerns. In this study, we will use the CONUT score to assess nutritional status and investigate its correlation with flow-mediated dilation test (FMD), a noninvasive vascular function test.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cardiovascular events
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Dialysis patients eligible for FMD testing
Key exclusion criteria
Patients who cannot undergo FMD testing due to reasons such as having shunts in both arms.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Masaki |
Organization
National Defense Medical College
Division name
Intensive Care Medicine
Zip code
359-8513
Address
3-2Namiki Tokorozawa
TEL
0429-95-1511
con320@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Masaki |
Organization
National Defence Medical College
Division name
Intensive Care Medicine
Zip code
359-8513
Address
3-2 Namiki Tokorozawa Saitama Japan
TEL
0429-95-1511
Homepage URL
con320@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Nobuyuki Masaki
Funding Source
Organization
National Defense Medical College
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Defense Medical College
Address
3-2 NAMIKI TOKOROZAWA JAPAN
Tel
0429951211
honrinri@ndmc.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
防衛医科大学校病院、川越南腎クリニック
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | 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
| 2026 | Year | 04 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Background: The flow-mediated dilation (FMD) test is a noninvasive assessment of vascular endothelial function that measures vasodilation induced by nitric oxide released from the vascular endothelium. Hemodialysis patients often experience cardiovascular complications, and poor nutritional status and frailty are significant concerns. Nutritional management is critical for hemodialysis patients; in addition to restricting the intake of electrolytes such as potassium and phosphorus and fluid intake, it is necessary to replenish proteins and minerals lost through the dialysis membrane. Nutritional status affects vascular endothelial function and may lead to further cardiovascular complications. Furthermore, frailty associated with malnutrition has been reported in numerous studies as a poor prognostic factor for dialysis patients. The CONUT score is widely used at our hospital as an indicator of nutritional status during admission screening. However, the relationship between the CONUT score and FMD testing remains unclear.
Therefore, with the cooperation of the Kawagoe Minami Kidney Clinic, we will conduct a retrospective study to investigate the relationship between FMD and the nutritional status, health status, and prognosis of dialysis patients.
Objective: To evaluate nutritional status using the CONUT score and clarify its correlation with FMD test indicators.
Research Questions and Academic/Social Significance:
We believe that significant insights can be gained from the results of this study. If FMD appears to be influenced by nutritional management or frailty, we will implement nutritional control and rehabilitation to improve FMD. If this leads to improvements in health status and prognosis, it will significantly contribute to improving the quality of care for dialysis patients.
Management information
Registered date
| 2026 | Year | 04 | Month | 04 | Day |
Last modified on
| 2026 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069991
