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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 14 June 2021
Main ID:  JPRN-UMIN000044518
Date of registration: 13/06/2021
Prospective Registration: No
Primary sponsor: Kansai Medical University Health Science Center
Public title: A Study on Targeting the Rate of Change of Muscle-Adipose Tissue for the Prevention of Cardiovascular Disease
Scientific title: A Study on Targeting the Rate of Change of Muscle-Adipose Tissue for the Prevention of Cardiovascular Disease - A Study on Targeting the Rate of Change of Muscle-Adipose Tissue for the Prevention of Cardiovascular Disease
Date of first enrolment: 2019/10/01
Target sample size: 1000
Recruitment status: Recruiting
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050861
Study type:  Observational
Study design:  Not selected Not selected  
Phase:  Not applicable
Countries of recruitment
Japan
Contacts
Name: yutaka    kimura
Address:  2-5-1 Shinmachi, Hirakata, Osaka Japan
Telephone: 072-804-0101
Email: kimuray@takii.kmu.ac.jp
Affiliation:  Kansai Medical University Health Science Center
Name: Satoshi    Kurose
Address:  2-5-1 Shinmachi, Hirakata, Osaka 573-1010 Japan
Telephone: 072-804-0101
Email: kurosesa@hirakata.kmu.ac.jp
Affiliation:  Kansai Medical University Health Science Center
Key inclusion & exclusion criteria
Inclusion criteria:
Exclusion criteria: Exclusion criteria
Patients who violate any of the following will not be included in this study
(1) Patients with severe hepatic or renal dysfunction
(2) Pregnant or lactating women
3) Patients with a history of wasting disease or condition causing extreme weight loss (severe infection, invasive surgery, malignancy, severe trauma, hyperthyroidism, etc.) within the past 6 months
(4) Patients after implantation of pacemakers and implantable defibrillators
5) Patients with psychiatric disorders that are difficult to manage
(6) Patients who are unable to obtain written consent or who do not understand the outline and purpose of the research
(7) Patients who are judged by the principal investigator to be inappropriate as research subjects.


Age minimum: 20years-old
Age maximum: 120years-old
Gender: Male and Female
Health Condition(s) or Problem(s) studied
obesity Sarcopenia
Intervention(s)
Primary Outcome(s)
The primary endpoints of this study will be changes in skeletal muscle mass and body fat mass.
Secondary Outcome(s)
Secondary endpoints will be body weight, blood pressure, glycolipid metabolic factors, adipokines, myokines, abdominal fat, arterial stiffness, physical fitness and physical activity, diet-related factors, and psychological indicators.
Secondary ID(s)
Source(s) of Monetary Support
Japan Society for the Promotion of Science
Secondary Sponsor(s)
Ethics review
Status: YES
Approval date: 01/10/2019
Contact:
rinriirb@hirakata.kmu.ac.jp
Kansai Medical University Center for Ethical Review
072-804-2440
rinriirb@hirakata.kmu.ac.jp
Results
Results available:
Date Posted:
Date Completed: 31/03/2022
URL:
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