UMIN-CTR Clinical Trial

Basic information
Public title	A Study on Targeting the Rate of Change of Muscle-Adipose Tissue for the Prevention of Cardiovascular Disease
Acronym	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
Scientific Title:Acronym	A Study on Targeting the Rate of Change of Muscle-Adipose Tissue for the Prevention of Cardiovascular Disease
Region	Japan

Condition
Condition	obesity Sarcopenia
Classification by specialty	Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study was conducted on patients with lifestyle-related diseases and no history of cardiovascular disease. To examine the relationship between changes in skeletal muscle mass and body fat mass and factors associated with cardiovascular disease after 6 months of exercise, diet, and psychological intervention in patients. Based on the results of the analysis, this study aims to set a target for the rate of change of skeletal muscle mass and body fat mass for the prevention of cardiovascular disease. The primary endpoints of this study will be changes in skeletal muscle mass and body fat mass, and 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.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The primary endpoints of this study will be changes in skeletal muscle mass and body fat mass.
Key secondary outcomes	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.

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	120 years-old >=
Gender	Male and Female
Key inclusion criteria	Selection Criteria Patients who meet all of the following criteria are eligible (1) Patients aged 20 years or older at the time of obtaining consent (2) Outpatient/inpatient: Any (3) Gender: No question (4) Patients who are able to use the physical activity meter used in this study (5) Patients who have received sufficient explanations for participation in this study and have given their free consent with full understanding.
Key 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.
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name yutaka Middle name Last name kimura
Organization	Kansai Medical University
Division name	Health Science Center
Zip code	573-1010
Address	2-5-1 Shinmachi, Hirakata, Osaka
TEL	072-804-0101
Email	kimuray@takii.kmu.ac.jp

Public contact
Name of contact person	1st name Satoshi Middle name Last name Kurose
Organization	Kansai Medical University
Division name	Health Science Center
Zip code	573-1010
Address	2-5-1 Shinmachi, Hirakata, Osaka
TEL	072-804-0101
Homepage URL
Email	kurosesa@hirakata.kmu.ac.jp

Sponsor
Institute	Kansai Medical University Health Science Center
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kansai Medical University Center for Ethical Review
Address	2-5-1 Shinmachi, Hirakata, Osaka
Tel	072-804-2440
Email	rinriirb@hirakata.kmu.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	関西医科大学付属病院

Other administrative information
Date of disclosure of the study information	2021 Year 06 Month 13 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	Enrolling by invitation
Date of protocol fixation	2019 Year 09 Month 10 Day
Date of IRB	2019 Year 10 Month 01 Day
Anticipated trial start date	2019 Year 10 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Study type and design Past and future starting cohort study Research and survey items The following items will be observed and examined, and the data will be used in this study. All of these items will be performed in routine medical care, and the frequency will be the same as in routine medical care. In the past-start cohort study, adipokines, myokines, and gene methylation rates will be assessed using blood specimens that are frozen and stored for secondary use in routine medical examinations and other studies. 1)Subject background: age, gender, diagnosis, medical history, height, weight, BMI, medication status, and lifestyle 2)Body composition: weight, BMI, skeletal muscle mass, body fat mass, limb skeletal muscle index, abdominal circumference 3)Blood tests: white blood cell, red blood cell, hemoglobin, lymphocyte count, total protein,albumin, AST, ALT Creatinine, BUN, Na, K, Total cholesterol, HDL cholesterol, LDL cholesterol, TG, GLU, HbA1c, IRI, CRP, Adipokine, Myokine, TSH, FT4, FT3 4)Methylation rate of genes related to obesity 5)Urinalysis: protein, sugar, occult blood, urobilinogen 6)CT imaging: visceral fat area, subcutaneous fat area, body fat mass, lean mass, bone density 7)Arterial stiffness test: RHI, baPWV, ABI, systolic blood pressure, diastolic blood pressure, heart rate 8)Autonomic nervous system test: sympathetic nerve activity, parasympathetic nerve activity 9) Cardiac function test: electrocardiogram, echocardiography 10) Chest x-ray 11) Physical fitness assessment: grip strength, walking speed, isokinetic leg muscle strength, resting metabolism, anaerobic metabolic threshold, maximal oxygen uptake 12) Physical activity: number of steps, energy expenditure, life time assessment

Management information
Registered date	2021 Year 06 Month 13 Day
Last modified on	2021 Year 06 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050861