UMIN-CTR Clinical Trial

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
Email	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
Email	taisuke_uchida@med.miyazaki-u.ac.jp

Sponsor
Institute	Division of Hematology, Diabetes, and Endocrinology, Department of Internal Medicine Department of Internal Medicine Faculty of Medicine, University of Miyazaki
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055176