UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048404 |
|---|---|
| Receipt number | R000055176 |
| Scientific Title | Prospective Observational Study on Prognostic Predictors of Sarcopenia and Sarcopenic Obesity |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2022/07/19 21:53:18 |
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Basic information
Public title
Prospective Observational Study on Prognostic Predictors of Sarcopenia and Sarcopenic Obesity
Acronym
Prospective Observational Study on Prognostic Predictors of Sarcopenia and Sarcopenic Obesity
Scientific Title
Prospective Observational Study on Prognostic Predictors of Sarcopenia and Sarcopenic Obesity
Scientific Title:Acronym
Prospective Observational Study on Prognostic Predictors of Sarcopenia and Sarcopenic Obesity
Region
| Japan |
Condition
Condition
sarcopenia
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploration of novel prognostic factors for sarcopenia and sarcopenic obesity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Survival curves for iliopsoas-visceral fat ratio with endpoints of death, institutionalization, and disease progression
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
(1) Patients who require an abdominal CT scan for medical treatment
(2) Patients who are 20 years of age or older at the time of consent
(3) Patients who have been fully informed about their participation in this study, and who have given written consent of their own free will based on their full understanding of the study.
Key exclusion criteria
(1) Subjects deemed inappropriate as research subjects by the principal investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Yamaguchi |
Organization
Department of Internal Medicine
Faculty of Medicine, University of Miyazaki
Division name
Division of Hematology, Diabetes, and Endocrinology
Zip code
8891692
Address
5200 Kihara, Kiyotake, Miyazaki 889-1692, Japan
TEL
0985859121
taisuke_uchida@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Taisuke |
| Middle name | |
| Last name | Uchida |
Organization
Department of Internal Medicine Faculty of Medicine, University of Miyazaki
Division name
Division of Hematology, Diabetes, and Endocrinology, Department of Internal Medicine
Zip code
8891692
Address
5200 Kihara, Kiyotake, Miyazaki 889-1692, Japan
TEL
0985859121
Homepage URL
taisuke_uchida@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Division of Hematology, Diabetes, and Endocrinology, Department of Internal Medicine
Department of Internal Medicine Faculty of Medicine, University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
Division of Hematology, Diabetes, and Endocrinology, Department of Internal Medicine
Department of Internal Medicine Faculty of Medicine, University of Miyazaki
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Miyazaki Hospital, Clinical Research Support Center
Address
5200 Kihara, Kiyotake, Miyazaki 889-1692, Japan
Tel
0985851510
rinken@med.miyazaki-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
| 2024 | Year | 12 | 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
| 2022 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to explore new prognostic factors for sarcopenia and sarcopenia-obesity. A prospective observational study will be conducted on patients who attended the hospital as outpatients or were hospitalized to investigate prognostic factors for sarcopenia and sarcopenia-obesity. This study will be conducted as an academic research activity to gain new knowledge in the field of endocrinology and metabolism.
Management information
Registered date
| 2022 | Year | 07 | Month | 19 | Day |
Last modified on
| 2022 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055176
