UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057185 |
|---|---|
| Receipt number | R000065368 |
| Scientific Title | Retrospective study on the relationship between InBody body composition analysis and salivary metabolomics in perioperative patients |
| Date of disclosure of the study information | 2025/03/03 |
| Last modified on | 2025/03/02 16:41:09 |
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Basic information
Public title
Retrospective study on the relationship between InBody body composition analysis and salivary metabolomics in perioperative patients
Acronym
Retrospective study on the relationship between InBody body composition analysis and salivary metabolomics in perioperative patients
Scientific Title
Retrospective study on the relationship between InBody body composition analysis and salivary metabolomics in perioperative patients
Scientific Title:Acronym
Retrospective study on the relationship between InBody body composition analysis and salivary metabolomics in perioperative patients
Region
| Japan |
Condition
Condition
Scheduled Surgery Patients
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Purpose of the study
This is a retrospective observational study that will analyze the relationship between body composition analysis using InBody and metabolic substance profiles using saliva metabolomics, using the results of body composition analysis using InBody for perioperative patients that have already been collected at our hospital. The purpose of this study is to explore the possibility of a new evaluation method for nutritional status by clarifying the relationship between body composition and metabolic profiles.
Basic objectives2
Others
Basic objectives -Others
Significance of the research
At our hospital, we perform InBody measurements and salivary metabolomics analysis on perioperative patients, and these data provide important information related to the nutritional and health status of patients. However, so far, the relationship between the results of these two different measurement methods has not been fully elucidated. This research will enable us to consider new indicators for nutritional assessment by analyzing in detail the relationship between body composition data and metabolites in saliva.
This approach will allow us to evaluate the usefulness of assessing the nutritional status of patients, particularly those for whom InBody measurements are difficult or impossible, using saliva metabolomics. In addition, it is hoped that the use of these methods to assess nutritional status will contribute to the development of rehabilitation intervention plans for perioperative patients.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The relationship between the phase angle and skeletal muscle index that can be collected from Inbody and the metabolic substances related to nutrition that are analyzed by salivary metabolomics.
Key secondary outcomes
The relationship between detailed analysis of body composition using InBody (muscle mass by body part, fat mass by body part, intracellular and extracellular water content by body part) and detailed analysis of salivary metabolomics (relationship between specific metabolic substances related to nutrition)
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 who had body composition analysis using InBody during the perioperative period within the target period and patients who had salivary metabolomics analysis during the same period when they visited the dentist
Key exclusion criteria
In case of refusal to participate in research
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Hayasaka |
Organization
Yamagata University Medical School Hospital
Division name
Department of Anesthesiology
Zip code
990-2331
Address
2-2-2, Iida-Nishi, Yamagata City, Yamagata Prefecture
TEL
0236285400
hayasakatatsuya1101@gmail.com
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Hayasaka |
Organization
Yamagata University Medical School Hospital
Division name
Department of Anesthesiology
Zip code
990-2331
Address
2-2-2, Iida-Nishi, Yamagata City, Yamagata Prefecture
TEL
0236285400
Homepage URL
hayasakatatsuya1101@gmail.com
Sponsor or person
Institute
Yamagata Universal Faculty of Medcine
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethical Review Committee of Yamagata University Faculty of Medicine
Address
2-2-2, Iida-Nishi, Yamagata City, Yamagata Prefecture
Tel
0236285015
ikekenkyu@jm.kj.yamagata-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
| 2025 | Year | 03 | Month | 03 | 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
36
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
Completed
Date of protocol fixation
| 2024 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 02 | Month | 28 | Day |
Other
Other related information
<Summary of Research Procedure>
Selection of patients:
The research period will be from January 1, 2021 to March 31, 2024, and data will be collected retrospectively from patients who visited the outpatient anesthesia department during this period and underwent body composition analysis using InBody, as well as from patients who visited the dental department during this period and underwent salivary metabolomics analysis. Patients who meet both conditions will be eligible.
<Data to be collected>
Medical records: age, gender, height, weight, etc.
InBody data: body water content, protein content, mineral content, body fat content, BMI, body fat percentage muscle mass by body part, fat mass by body part, water content by body part, intracellular and extracellular water content, skeletal muscle mass, basal metabolic rate, body cell mass, skeletal muscle index SMI, phase angle
Saliva metabolomics data: results of saliva metabolomics analysis 89 metabolic substances such as pyruvate, butyrate, lactate, and citrate
Statistical analysis: Statistical analysis of the relationship between the results of body composition analysis using InBody and the results of salivary metabolomics analyzed. A correlation coefficient of r>0.6 or an AUC>0.7 or p<0.05 in ROC analysis of nutritional status is considered to indicate a significant relationship.
Management information
Registered date
| 2025 | Year | 03 | Month | 02 | Day |
Last modified on
| 2025 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065368
