UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060540 |
|---|---|
| Receipt number | R000068511 |
| Scientific Title | A Retrospective Observational Study Evaluating the Association Between Flow-Mediated Dilation (FMD) and the Coefficient of Variation of R-R Intervals (CVRR) in Patients with Diabetes |
| Date of disclosure of the study information | 2026/01/31 |
| Last modified on | 2026/01/31 22:08:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigation of the Relationship Between Endothelial Function and Autonomic Nervous Function in Patients with Diabetes: A Retrospective Observational Study Using FMD and CVRR
Acronym
FMD-CVRR Study
Scientific Title
A Retrospective Observational Study Evaluating the Association Between Flow-Mediated Dilation (FMD) and the Coefficient of Variation of R-R Intervals (CVRR) in Patients with Diabetes
Scientific Title:Acronym
Correlation Study of FMD and CVRR
Region
| Japan |
Condition
Condition
Diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the association between endothelial function (FMD) and autonomic nervous function (CVRR) in patients with diabetes mellitus, and to evaluate the relationships between these parameters and clinical background factors.
Basic objectives2
Others
Basic objectives -Others
Exploration of the relationships between physiological parameters
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between flow-mediated dilation (FMD) and the coefficient of variation of R-R intervals (CVRR), using measurement data obtained within 3 months of the FMD examination.
Key secondary outcomes
Evaluation of the associations between FMD and CVRR and various clinical background factors, including age, sex, BMI, HbA1c, lipid parameters, blood pressure, CAVI, diabetic retinopathy, neuropathy, nephropathy, and endocrine markers.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with diabetes mellitus
Patients who underwent both FMD and CVRR measurements
Patients with required clinical data available in the electronic medical record
Key exclusion criteria
Patients without available FMD or CVRR data
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takanobu |
| Middle name | |
| Last name | Saheki |
Organization
Kagawa University Hospital
Division name
Department of Clinical Laboratory
Zip code
761-0793
Address
Kagawa University Hospital 1750-1 Ikenobe, Miki-cho, Kita-gun,
TEL
087-891-2230
saheki.takanobu@kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Takanobu |
| Middle name | |
| Last name | Saheki |
Organization
Kagawa University Hospital
Division name
Department of Clinical Laboratory
Zip code
761-0793
Address
Kagawa University Hospital 1750-1 Ikenobe, Miki-cho, Kita-gun,
TEL
087-891-2230
Homepage URL
saheki.takanobu@kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University
Institute
Department
Personal name
Takanobu Saheki
Funding Source
Organization
Kagawa University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Support Center, Kagawa University Hospital
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan
Tel
087-891-2280
chiken-m@kagawa-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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 31 | 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
| 2025 | Year | 09 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective observational study using existing clinical data obtained during routine medical care.No additional intervention or treatment allocation is performed.The study analyzes the association between flow-mediated dilation (FMD), the coefficient of variation of RR intervals (CVRR),and relevant clinical parameters.
Management information
Registered date
| 2026 | Year | 01 | Month | 31 | Day |
Last modified on
| 2026 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068511
