UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060577 |
|---|---|
| Receipt number | R000069288 |
| Scientific Title | Development and Validation of a Cardiovascular High-Risk Identification Algorithm Combining BMI and Body Muscle-to-Fat Ratio (BMFR) in Patients with Diabetes Mellitus |
| Date of disclosure of the study information | 2026/03/01 |
| Last modified on | 2026/02/04 12:48:54 |
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Basic information
Public title
Combined Use of BMI and Body Muscle-to-Fat Ratio (BMFR) for Identifying High-Risk Patients with Diabetes Mellitus
Acronym
BMI-BMFR Risk Study
Scientific Title
Development and Validation of a Cardiovascular High-Risk Identification Algorithm Combining BMI and Body Muscle-to-Fat Ratio (BMFR) in Patients with Diabetes Mellitus
Scientific Title:Acronym
BMI-BMFR Risk Study
Region
| Japan |
Condition
Condition
Type 2 Diabetes Mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether the combination of BMI and BMFR can identify cardiovascular high risk patients who are not detected by BMI alone, and to develop a novel algorithm based on the combination of BMI and BMFR for risk stratification
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence of cardiovascular disease high risk status defined as 2 or more of the following conditions: hypertension, dyslipidemia, fatty liver, chronic kidney disease, or hyperuricemia, and its identification based on BMFR classification
Key secondary outcomes
1. Prevalence of high risk stratified by BMI and BMFR, 2. Association between four groups (normal, hidden obesity, healthy obesity, metabolic obesity) and CVD risk, 3. Odds ratios estimated by logistic regression analysis
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes mellitus treated at our clinic
Aged 18 years or older
Those who underwent body composition assessment enabling measurement of skeletal muscle mass and fat mass
Individuals in whom BMI and BMFR can be calculated
Patients whose medical records allow assessment of hypertension, dyslipidemia, fatty liver, chronic kidney disease, and hyperuricemia
Key exclusion criteria
Patients with missing body composition data
Individuals in whom body composition measurement is contraindicated
Patients with active malignancy
Those with marked fluid imbalance due to severe heart failure, liver failure, or renal failure
Patients judged inappropriate for inclusion by the investigator
Target sample size
118
Research contact person
Name of lead principal investigator
| 1st name | Noboru |
| Middle name | |
| Last name | Kurinami |
Organization
Jinnouchi Hospital
Division name
Internal Medicine
Zip code
862-0976
Address
6-2-3 Kuhonji, Chuo-ku, Kumamoto City, Kumamoto
TEL
0963630011
kurinami@jinnouchi.or.jp
Public contact
Name of contact person
| 1st name | NOBORU |
| Middle name | |
| Last name | KURINAMI |
Organization
Jinnouchi Hospital
Division name
Internal Medicine
Zip code
862-0976
Address
6-2-3 Kuhonji, Chuo-ku, Kumamoto City, Kumamoto
TEL
0963630011
Homepage URL
kurinami@jinnouchi.or.jp
Sponsor or person
Institute
Jinnouchi Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Jinnouchi
Address
6-2-3 Kuhonji, Chuo-ku, Kumamoto City, Kumamoto
Tel
0963630011
kurinami@jinnouchi.or.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 | 03 | 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 | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study without any intervention, based on a cross-sectional analysis of clinical information and body composition data obtained in routine clinical practice. The study was designed on the basis of our previous report (J Clin Med Res. 2021;13(7):387-391) to evaluate the validity of a novel algorithm combining BMI and Body Muscle-to-Fat Ratio (BMFR) for identifying cardiovascular disease (CVD) high-risk patients. Data are collected from medical records and bioelectrical impedance analysis, and no additional invasive procedures are performed.
Management information
Registered date
| 2026 | Year | 02 | Month | 04 | Day |
Last modified on
| 2026 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069288
