UMIN-CTR Clinical Trial

Basic information
Public title	Differences of skeletal muscle after reduction of weight in the patients with obesity between internal and surgical treatment
Acronym	Skeletal muscle in the patients with obesity between internal and surgical treatment
Scientific Title	Differences of skeletal muscle after reduction of weight in the patients with obesity between internal and surgical treatment
Scientific Title:Acronym	Skeletal muscle in the patients with obesity between internal and surgical treatment
Region	Japan

Condition
Condition	Obesity
Classification by specialty	Cardiology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the result of surgical treatment with obesity patients at health science center. Comparison of the change of muscle mass between internal and surgical treatment with obesity patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of skeletal muscle changes between internal and surgical treatment
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	Outpatients at the Kansai Medical University from April 2013 to March 2018. And include following 1.Patients who is more than 20 years old obtaining informed consent. 2.Patients who participate the internal treatment or surgical treatment for a certain period. 3.Independent living . 4.Participants with sufficient understanding and informed consent for this study.
Key exclusion criteria	1.Patients with serious heart failure,arrhythmia,respiratory failure,metabolic diseases. 2.Patients who has underlying disease which is serious,untreated and insufficient treatment. 3.Psychiatric patients who is difficult to participate in this study. 4.Patients whom principal investigators and the research supervisor.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yutaka Kimura
Organization	Kansai Medical University Hospital
Division name	Health Science
Zip code
Address	2-3-1 Shinmachi Hirakata city Osaka Japan
TEL	0728040101
Email	kimuray@hirakata.kmu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hiromi Tsutsumi
Organization	Kansai Medical University
Division name	Health Science
Zip code
Address	2-5-1 Shinmachi Hirakata city Osaka Japan
TEL	0728040101
Homepage URL
Email	tsutsumi@hirakata.kmu.ac.jp

Sponsor
Institute	Kansai Medecal University Hospital
Institute
Department

Funding Source
Organization	Nothing
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
Address
Tel
Email

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	2016 Year 10 Month 15 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	Terminated
Date of protocol fixation	2016 Year 09 Month 12 Day
Date of IRB	2016 Year 10 Month 13 Day
Anticipated trial start date	2016 Year 09 Month 12 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Prospective observational study

Management information
Registered date	2016 Year 10 Month 11 Day
Last modified on	2021 Year 08 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027937