UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024366 |
|---|---|
| Receipt number | R000027937 |
| Scientific Title | Differences of skeletal muscle after reduction of weight in the patients with obesity between internal and surgical treatment |
| Date of disclosure of the study information | 2016/10/15 |
| Last modified on | 2021/08/19 20:11:09 |
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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
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
tsutsumi@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medecal University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027937
